Federal Executive Branch
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SEC Commissioner Uyeda Issues Statement on Proposing Registered Offering Reform and Enhancement of Emerging Growth Company Accommodations and Simplification of Filer Status for Reporting Companies
WASHINGTON, May 20 -- The Securities and Exchange Commission issued the following statement on May 19, 2026, by Commissioner Mark T. Uyeda on Proposing Registered Offering Reform and Enhancement of Emerging Growth Company Accommodations and Simplification of Filer Status for Reporting Companies:
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Today, the Commission proposes rules to update its rulebook with respect to conducting shelf offerings and to enhance and simplify the registration and reporting framework for smaller public companies. These proposals reflect a commitment to improve the core features of the SEC's registration and
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WASHINGTON, May 20 -- The Securities and Exchange Commission issued the following statement on May 19, 2026, by Commissioner Mark T. Uyeda on Proposing Registered Offering Reform and Enhancement of Emerging Growth Company Accommodations and Simplification of Filer Status for Reporting Companies:
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Today, the Commission proposes rules to update its rulebook with respect to conducting shelf offerings and to enhance and simplify the registration and reporting framework for smaller public companies. These proposals reflect a commitment to improve the core features of the SEC's registration andreporting system. They build upon--and improve--the SEC rulebook in a manner that reflects the agency's observations and awareness of contemporary market practices that have developed over the past two decades.
The First Proposal Builds Upon the Successes of the Shelf Registration Framework
With regard to Registered Offering Reform, the proposal would modernize the shelf registration framework. The state of communications and information technologies has evolved significantly since the last time that the Commission made substantial changes to the shelf registration offering process as part of the Securities Act Offering Reform rulemaking in 2005.[1]
Market practices, including how material information is distributed and consumed by investors, have changed dramatically since then. More tools are available to obtain information on financial markets, individual companies, and financial products than ever before. Disclosure is largely available in real time today, far advanced from where it was twenty years ago. For context, in 2005, Chairman Cox noted how technology was impacting financial markets with respect to the distribution of proxy materials:
With the holiday season in full swing ... it's difficult not to notice the proliferation of electronic gadgets being advertised as the perfect holiday gift. We can only guess how many Americans will get a USB key as a stocking stuffer, or a cell phone that takes pictures and surfs the Web, or even an iPod that plays not only MP3s, but video.[2]
Chairman Cox's reference to the iPod reminds us that when the Commission last examined shelf registration in a comprehensive manner, the iPhone had not even been rolled out yet.[3] Moreover, the technology available in 2005 substantially differed from the technology available in 1983, the year that the SEC adopted the original shelf registration framework.[4] Instead of carrying around that iPod back then, you might have had a cassette-playing Sony Walkman.
Communication and information technologies have continued to change. Smart phones, cloud computing, social media networks, video streaming, structured data, and third-party messaging services are common features of the investment ecosystem in 2026 and the SEC's rulebook should reflect that environment.
The Registered Offering Reform proposal would facilitate capital formation by expanding access to Form S-3 and streamline the registration and communication benefits for public companies.[5] This would provide meaningful increases in transactional flexibility to a range of smaller entities and improve their access to capital post-IPO. The proposal would also limit unnecessary regulatory duplication by preempting the need to obtain, in certain cases, registration and qualification from dozens of individual state securities regulators, where the investor protection benefits may not be commensurate with the corresponding regulatory hurdles to raising capital.
The Second Proposal Streamlines and Simplifies SEC Reporting
The Commission also proposes the Enhancement of Emerging Growth Company Accommodations and Simplification of Filer Status for Reporting Companies.[6] Among other changes, the proposal would raise the public float threshold for large accelerated filer (LAF) status from the current $700 million to $2 billion, at which threshold the category would represent approximately 19 percent of reporting companies and 93.5 percent of the current total market public float.[7] This would reduce regulatory burdens while ensuring that the vast majority of the public float remains subject to the full set of disclosure requirements. The proposal would also simplify the framework by categorizing all companies that are not LAFs as non-accelerated filers (NAFs).
Additionally, the Commission is proposing to create a subcategory of NAFs constituting the smallest filers, termed small non-accelerated filers (SNFs), with extended periodic reporting deadlines. Scaling regulatory obligations for smaller businesses may incentivize companies to go--and remain--public. It takes the SEC one step closer to making the consequences and burdens of being a public company less onerous--and less off-putting--for small issuers.
Lastly, the proposal would extend nearly all disclosure scaling and accommodations available to smaller reporting companies and emerging growth companies to NAFs, including the internal control over financial reporting (ICFR) auditor attestation exemption. These aspects of the proposal build upon the success of the JOBS Act of 2012.[8] These successes reflect an important point: management and boards of public companies exist to focus on operating and managing their businesses--and not to spend outsized amounts of time and resources on regulatory compliance obligations.
Combined, these proposals advance the Commission's mission of protecting investors and facilitating capital formation and are long overdue.[9] I thank the staff in the Division of Corporation Finance, the Division of Economic and Risk Analysis, the Division of Investment Management, the Division of Trading and Markets, the EDGAR Business Office, the Office of the General Counsel, the Office of the Chief Accountant, the Office of Financial Management, and the many other offices that have contributed to this release. I look forward to hearing the views of market participants on these issues.
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[1] Securities Offering Reform, Release No. 33-8591 (July 19, 2005).
[2] Chairman Christopher Cox, Opening Statement at SEC Open Meeting (Nov. 29, 2005) (consideration of a proposal to make Internet access an acceptable way for investors to get their proxy materials), available at https://www.sec.gov/news/speech/spch112905cc.htm.
[3] Apple would not formally introduce the iPhone until 2007. See Apple, Inc., Press Release, Apple Reinvents the Phone with iPhone (Jan. 9, 2007), available at https://www.apple.com/newsroom/2007/01/09Apple-Reinvents-the-Phone-with-iPhone/.
[4] Shelf Registration, Release No 33-6499 (Nov. 17, 1983), 48 FR 52889 (Nov. 23, 1983), available at https://www.federalregister.gov/citation/48-FR-52889.
[5] Registered Offering Reform, Release No. 33-11418 (May 19, 2026), available at https://www.sec.gov/files/rules/proposed/2026/33-11418.pdf.
[6] Enhancement of Emerging Growth Company Accommodations and Simplification of Filer Status for Reporting Companies, Release No. 33-11419 (May 19, 2026), available at https://www.sec.gov/files/rules/proposed/2026/33-11419.pdf.
[7] Id. at 36.
[8] Pub. L. No. 112-106, 126 Stat. 306 (2012), sec. 103 (codified at 15 U.S.C. 7262(b)).
[9] For prior remarks on capital formation, see Commissioner Mark T. Uyeda, Remarks at the "Going Public in the 2020s" Conference; Columbia Law School/Business School Program in the Law and Economics of Capital Markets (Mar. 3, 2023), available at https://www.sec.gov/newsroom/speeches-statements/uyeda-remarks-going-public-conference-030323-remarks-going-public-2020s-conference-columbia-law-schoolbusiness-school-program-law-economics; Commissioner Mark T. Uyeda, Remarks at the Practising Law Institute's 55th Annual Institute on Securities Regulation (Nov. 7, 2023), available at https://www.sec.gov/newsroom/speeches-statements/uyeda-remarks-practicing-law-institute-110723; and Acting Chairman Mark T. Uyeda, Remarks at the Florida Bar's 41st Annual Federal Securities Institute and M&A Conference (Feb. 24, 2025), available https://www.sec.gov/newsroom/speeches-statements/uyeda-remarks-florida-bar-022425.
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Original text here: https://www.sec.gov/newsroom/speeches-statements/uyeda-statement-proposing-registered-offering-reform-and-enhancement-of-emerging-growth-company-accommodations-and-simplification-of-filer-status-for-reporting-companies-051926
SEC Commissioner Peirce Issues Statement on Proposing Releases for Registered Offering Reform and Enhancement of Emerging Growth Company Accommodations and Simplification of Filer Status for Reporting Companies
WASHINGTON, May 20 -- The Securities and Exchange Commission issued the following statement on May 19, 2026, by Commissioner Hester M. Peirce on Proposing Releases for Registered Offering Reform and Enhancement of Emerging Growth Company Accommodations and Simplification of Filer Status for Reporting Companies:
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Becoming and remaining a public company is never going to be easy, but the Commission has an ongoing responsibility to ensure that the burdens associated with going and being public offer a commensurate benefit. As markets and technology change, the rules governing public companies
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WASHINGTON, May 20 -- The Securities and Exchange Commission issued the following statement on May 19, 2026, by Commissioner Hester M. Peirce on Proposing Releases for Registered Offering Reform and Enhancement of Emerging Growth Company Accommodations and Simplification of Filer Status for Reporting Companies:
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Becoming and remaining a public company is never going to be easy, but the Commission has an ongoing responsibility to ensure that the burdens associated with going and being public offer a commensurate benefit. As markets and technology change, the rules governing public companiesalso may need to change. Today, the Commission is proposing amendments that if adopted would improve companies' access to our public markets and simplify the regulatory landscape for publicly traded companies.
The registered offering reform proposal directly addresses how companies raise capital in the public markets as well as how technological advancements have obviated the need for some of our more restrictive rules. Take, for example, the one-year seasoning requirement for Form S-3 eligibility and the $75 million public float threshold for unfettered access to Form S-3, both of which we are proposing today to eliminate. In the early 1980s the Commission stated that such eligibility criteria "are based on the Commission's belief that information about companies using the form already is known or is so readily available that it need not be repeated in a prospectus."[1] But now, nearly fifty years later, information is more readily available than ever. Given the ubiquity of internet usage and thirty years of mandated electronic filings,[2] the speed of information dissemination no longer seems a valid reason to curtail access to short-form registration statements.[3]
Some technical and mechanical changes being proposed today should reduce the headaches induced by our current prescriptive ruleset. For example, we are proposing to modify how delaying amendments in registration statements function. No longer will issuers have to include a delaying amendment to prevent a registration statement from inadvertently going effective.
More consequential changes in the filer status reform proposal would ameliorate certain woes associated with being a public company. Companies, and even their lawyers, need flow charts, cheat sheets, and lots of caffeine to decipher their filer status under the current framework. Aggravating this burdensome annual exercise is the ease with which companies can fall in and out of a particular filer status. The simplified framework proposed today would largely address both problems.
The proposed changes to filer status thresholds also would reduce smaller public companies' disclosure burdens. Since the large accelerated filer status was adopted over 20 years ago[4], the number of companies subjected to our most stringent disclosure requirements has nearly doubled.[5] Recalibrating the large accelerated filer status threshold, which we propose to do, would be a positive step toward right-sizing the regulatory burden of being a public company. Currently, companies with just over $700 million in public float face the same set of requirements as the largest public companies in our markets.
I am happy to support both of today's proposals as part of this Commission's broader goal of facilitating capital formation and encouraging entrance into our public markets. Modernizing rules to take account of real-world advancements is a worthwhile endeavor. I thank the staff in the Division of Corporation Finance, Division of Economic and Risk Analysis, Division of Investment Management, Division of Trading and Markets, Office of the General Counsel, Office of the Chief Accountant, the EDGAR Business Office, and the Office of Financial Management for their efforts on today's proposals. And, of course, I look forward to hearing the views of commenters on all aspects of both proposals.
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[1] Reproposal of Comprehensive Revision to System for Registration of Securities Offerings, Release No. 33-6331 (Aug. 6, 1981) [46 FR 41902, 41913 (Aug. 18, 1981)].
[2] Registered Offering Reform, Release No. 33-11418 (May 19, 2026) (the "Registered Offering Reform Proposing Release") fn. 34, available at https://www.sec.gov/files/rules/proposed/2026/33-11418.pdf. ("In 1993, the Commission began mandating electronic filings on EDGAR on a phased-in basis. See Rulemaking for EDGAR System, Release No. 33-6977 (Feb. 23, 1993) [58 FR 14628 (Mar. 18, 1993)]. This phase-in culminated in all corporate issuers becoming subject to electronic filing requirements in 1996. See Rulemaking for EDGAR System, Release No. 33-7122 (Dec. 19, 1994) [59 FR 67752 (Dec. 30, 1994)].").
[3] Such developments also animate other positive changes contained in this proposal. See e.g., proposal to allow issuers to incorporate by reference on Form S-1 prior to filing a Form 10-K for the issuer's most recently completed fiscal year. See Registered Offering Reform Proposing Release at 142.
[4] Revisions to Accelerated Filer Definition and Accelerated Deadlines for Filing Periodic Reports, Release No. 33-8644 (Dec. 21, 2005) [70 FR 76626 (Dec. 27, 2005)].
[5] Enhancement of Emerging Growth Company Accommodations and Simplification of Filer Status for Reporting Companies, Release No. 33-11419 (May 19, 2026), pg. 42, available at https://www.sec.gov/files/rules/proposed/2026/33-11419.pdf
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Original text here: https://www.sec.gov/newsroom/speeches-statements/peirce-statement-proposing-releases-ror-051926
National Academies of Sciences, Engineering and Medicine: Technologies and Approaches Needed to Shore Up Interconnected U.S. Energy and Water Systems, Says New Report
WASHINGTON, May 20 (TNSrep) -- The National Academies of Sciences, Engineering and Medicine issued the following news release:
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New Technologies and Approaches Needed to Shore Up Interconnected U.S. Energy and Water Systems, Says New Report
To strengthen the reliability and resiliency of the nation's energy and water systems, the U.S. Department of Energy should develop innovative technology and infrastructure at the intersection of the two systems through a suite of pilot programs, says a new report from the National Academies of Sciences, Engineering, and Medicine. U.S. energy and water
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WASHINGTON, May 20 (TNSrep) -- The National Academies of Sciences, Engineering and Medicine issued the following news release:
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New Technologies and Approaches Needed to Shore Up Interconnected U.S. Energy and Water Systems, Says New Report
To strengthen the reliability and resiliency of the nation's energy and water systems, the U.S. Department of Energy should develop innovative technology and infrastructure at the intersection of the two systems through a suite of pilot programs, says a new report from the National Academies of Sciences, Engineering, and Medicine. U.S. energy and watersystems are profoundly interconnected, and disruptions can cascade rapidly across both, affecting public health, economic activity, environmental quality, and national security.
Energy and water systems are often managed separately, however, and regional environmental, socioeconomic, and political conditions can vary widely, making a single national approach inadequate for addressing the range of challenges facing the systems. For example, data centers are placing new and increasing strain on the electric grid and using significant quantities of water in some areas, while other stressors such as extreme weather are testing aging infrastructure and exposing systemic vulnerabilities. The report points to Winter Storm Uri in 2021 when prolonged power outages disrupted water treatment and distribution across Texas, underscoring how coupled energy and water systems are.
"The breadth of challenges and contexts across the energy-water nexus are extraordinary and will take a multipronged approach to address," said Katharine Jacobs, chair of the committee that wrote the report and director of the Center for Climate Adaptation Science and Solutions and professor of environmental science at the University of Arizona. "Our report offers a foundation for DOE to integrate cross-sector collaboration and regional knowledge to protect and strengthen our communities and country."
Pilot programs could demonstrate technologies that advance resilience and reduce structural risks to energy and water systems, the report says, and allow DOE to facilitate the deployment of integrated energy-water technologies that are attuned to local needs and constraints. In addition, pilot programs could offer a platform to improve access to energy and clean water, as well as create skilled jobs in the energy sector. The report provides strategies and considerations for how to build a suite of pilot projects and ensure that investments yield measurable, long-term benefits and effectively mitigate risk.
The pilot programs should be developed with local resource constraints and community needs at the forefront, the report emphasizes. DOE should take into account the costs and benefits of distributed energy and water infrastructure and region-specific challenges. The report also recommends that the pilot programs should support data collection and prioritize proactive risk management systems.
The absence of a specific federal agency dedicated to water management issues that can centralize, coordinate, and evaluate data has hindered the federal government's ability to develop cohesive, cross-sector water programs, the report notes. At the same time, water management decisions are inherently local and context-specific, shaped by regional hydrology, governance structures, and community needs, making a fully centralized approach neither practical nor desirable. However, within this landscape, entities like DOE's Hydropower and Hydrokinetic Office have the capacity to serve as conveners and coordinators at the federal level without supplanting state, tribal, and local authorities. DOE should therefore focus on creating effective management structures that align budgets and strategies, extend existing benefits while avoiding duplication of effort, and foster collaboration, transparency, and partnerships with industrial and agricultural partners.
The study was undertaken by the Committee on Enabling DOE Regional Energy-Water Technology Pilots and sponsored by the U.S. Department of Energy.
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The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, engineering, and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln.
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View report here: https://www.nationalacademies.org/projects/DELS-WSTB-23-02/publication/29347
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Original text here: https://www.nationalacademies.org/news/new-technologies-and-approaches-needed-to-shore-up-interconnected-u-s-energy-and-water-systems-says-new-report
NRC Accepts University of Illinois Application to Build Advanced Microreactor, Kicking Off Formal Review
WASHINGTON, May 20 -- The Nuclear Regulatory Commission issued the following news release:
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NRC Accepts University of Illinois Application to Build Advanced Microreactor, Kicking Off Formal Review
Rockville, Md. -- The Nuclear Regulatory Commission has formally accepted the University of Illinois Urbana-Champaign's application to build an advanced microreactor on its campus, launching a detailed safety and environmental review of a project that would mark a significant milestone in university nuclear research.
The application, submitted March 31, proposes a reactor based on NANO Nuclear
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WASHINGTON, May 20 -- The Nuclear Regulatory Commission issued the following news release:
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NRC Accepts University of Illinois Application to Build Advanced Microreactor, Kicking Off Formal Review
Rockville, Md. -- The Nuclear Regulatory Commission has formally accepted the University of Illinois Urbana-Champaign's application to build an advanced microreactor on its campus, launching a detailed safety and environmental review of a project that would mark a significant milestone in university nuclear research.
The application, submitted March 31, proposes a reactor based on NANO NuclearEnergy's KRONOS Micro Modular Reactor design, a next-generation system using helium cooling and a molten-salt heat transfer process engineered for enhanced safety and efficiency.
What Happens Next
NRC technical staff have begun a rigorous evaluation of the proposed reactor's safety and environmental impacts. Within days, the agency will also publish a Federal Register notice opening a 30-day window for members of the public and nearby communities to request a formal legal hearing on the application.
If a construction permit is granted, the university would still need to apply for and receive a separate NRC operating license before the reactor could start up.
Why It Matters
If approved, the project would give University of Illinois students and researchers handson access to cutting-edge reactor technology, training the next generation of nuclear engineers while providing a real-world demonstration platform for microreactor designs that could one day power remote communities, military bases and industrial facilities across the country.
More information on the NRC's review is available at nrc.gov.
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The U.S. Nuclear Regulatory Commission was created as an expert, technical agency to protect public health, safety, and security, and regulate the civilian use of nuclear materials, including enabling the deployment of nuclear power for the benefit of society. Among other responsibilities, the agency issues licenses, conducts inspections, initiates and enforces regulations, and plans for incident response. The global gold standard for nuclear regulation, the NRC is collaborating with interagency partners to implement reforms outlined in new Executive Orders and the ADVANCE Act to streamline agency activities and enhance efficiency.
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Original text here: https://www.nrc.gov/sites/default/files/cdn/doc-collection-news/2026/26-055.pdf
FDIC Chairman Hill Issues Statement on Proposal to Revise the CAMELS Rating System
WASHINGTON, May 20 -- The Federal Deposit Insurance Corporation issued the following statement on May 19, 2026, by Chairman Travis Hill on the Proposal to Revise the CAMELS Rating System:
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Today's proposal represents an important step in the FDIC's ongoing efforts to reform bank supervision to focus on factors that materially affect an institution's financial condition and risk profile.
The FFIEC first developed the Uniform Financial Institutions Rating System, commonly referred to as CAMELS, in 1979 to establish a uniform framework to evaluate an institution's "financial condition, compliance
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WASHINGTON, May 20 -- The Federal Deposit Insurance Corporation issued the following statement on May 19, 2026, by Chairman Travis Hill on the Proposal to Revise the CAMELS Rating System:
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Today's proposal represents an important step in the FDIC's ongoing efforts to reform bank supervision to focus on factors that materially affect an institution's financial condition and risk profile.
The FFIEC first developed the Uniform Financial Institutions Rating System, commonly referred to as CAMELS, in 1979 to establish a uniform framework to evaluate an institution's "financial condition, compliancewith laws and regulations, and overall operating soundness."/1 The CAMELS framework has not been modified since 1996, while the banking industry has undergone significant changes.
The proposal is intended to modify how the overall composite and individual component ratings are described to shift the emphasis away from a bank's process for managing risks and towards factors and risks that materially impact a bank's financial condition. Under the proposal, a bank's internal controls and risk management would remain relevant in the overall evaluation, but the primary focus of the ratings system would be on fundamental financial risks most pertinent to safety and soundness.
Key changes would include reducing the influence of the Management component rating on the overall composite rating;/2 limiting the impact of specialty exam considerations to those that pose material financial risk; and focusing the ratings definitions and evaluation factors on the areas most impactful to an institution's financial condition.
I thank the staffs of the FFIEC and its member entities for their work on the proposal. I encourage robust feedback and look forward to reviewing comments.
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1/ Federal Financial Institutions Examination Council, Uniform Rating System (PDF), (Nov. 13, 1979) p. 1.
2/ Under the proposal, among other changes, the Management rating would no longer be given "special consideration" when assigning the composite rating, and the composite rating definitions would deemphasize consideration of management compared to the existing definitions.
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Original text here: https://www.fdic.gov/news/speeches/2026/statement-chairman-travis-hill-proposal-revise-camels-rating-system
FDA Center for Drug Evaluation & Research Issues Warning Letter to Naseem A. Jaffrani, M.D.
WASHINGTON, May 20 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Naseem A. Jaffrani, M.D. from its Center for Drug Evaluation and Research:
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Recipient: Naseem A. Jaffrani, M.D., 3311 Prescott Road, Suite 310, Alexandria, LA 71301, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
FDA Ref. No.: 26-HFD-45-05-01
Dear Dr. Jaffrani:
This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection
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WASHINGTON, May 20 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Naseem A. Jaffrani, M.D. from its Center for Drug Evaluation and Research:
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Recipient: Naseem A. Jaffrani, M.D., 3311 Prescott Road, Suite 310, Alexandria, LA 71301, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
FDA Ref. No.: 26-HFD-45-05-01
Dear Dr. Jaffrani:
This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspectionconducted at your clinical site between February 24 and March 13, 2025. The investigator representing FDA reviewed your conduct of the following clinical investigations:
* Protocol (b)(4), "(b)(4)," of the investigational drug (b)(4), performed for (b)(4)
* Protocol (b)(4), "(b)(4)," of the investigational drug (b)(4), performed for (b)(4)
This inspection was conducted as a part of FDA's Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.
At the conclusion of the inspection, the FDA investigator presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your March 31, 2025, written response to the Form FDA 483.
From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated March 31, 2025, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312), governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following:
You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].
As a clinical investigator, you are required to ensure that your clinical investigations are conducted in accordance with the investigational plan. The investigational plans for Protocol (b)(4) and Protocol (b)(4) required you to report all serious adverse events (SAEs) to the sponsor within 24 hours of your knowledge of the occurrence.
You failed to adhere to this requirement. Specifically:
1. The investigational plan for Protocol (b)(4) required every SAE, regardless of causality, occurring after the subject has provided informed consent and until 16 weeks after the last dose of study drug, to be reported to (b)(4) safety team immediately, without undue delay, but under no circumstances later than 24 hours after your learning about the events/1.
Specifically, Subject (b)(6) was consented on July 6, 2020, and the last dose of study drug occurred on July 8, 2024. This subject experienced the following SAEs, which were not reported to the sponsor's safety team within the required time frame:
a. The subject experienced an SAE of non-ST elevation myocardial infarction (NSTEMI) between September 1 and 3, 2022, which you became aware of on September 2, 2022. However, this SAE was not initially reported to the sponsor's safety team until September 26, 2022.
b. The subject experienced SAEs of COVID-19 pneumonia, chronic obstructive pulmonary disease exacerbation, and hospitalization for congestive heart failure between January 5 and 9, 2023, which you became aware of on January 5, 2023. However, these SAEs were not initially reported to the sponsor's safety team until February 21, 2023; April 3, 2023; and May 1, 2023, respectively.
c. The subject experienced SAEs of pulmonary embolism and deep vein thrombosis post-COVID-19 pneumonia between January 13 and 17, 2023, which you became aware of on January 13, 2023. However, these SAEs were not initially reported to the sponsor's safety team until May 1, 2023.
d. The subject experienced an SAE of worsening ischemic cardiomyopathy between October 3 and November 16, 2024, which you became aware of on November 13, 2024. However, this SAE was not initially reported to the sponsor's safety team until November 24, 2024.
2. The investigational plan for Protocol (b)(4) required all SAEs occurring from the time of informed consent until End of Study to be reported to Medpace Clinical Safety within 24 hours of knowledge of the occurrence, regardless of the investigator's determination as to relatedness. The IRB suspended enrollment and dosing for Protocol (b)(4) on November 27, 2024. Specifically:
a. Subject (b)(6) was consented on January 18, 2023. This subject experienced an SAE of post-operative neck hematoma, after a right carotid endarterectomy, between August 29 and September 2, 2023, which you became aware of on September 11, 2023. However, this SAE was not initially reported to the safety team until September 15, 2023.
b. Subject (b)(6) was consented on July 17, 2023. This subject was hospitalized for hypotension between (b)(6), which you became aware of on January 30, 2025. However, this SAE was not initially reported to the safety team until February 7, 2025.
In your March 31, 2025, written response to the Form FDA 483, you acknowledged that you failed to meet your responsibilities as a clinical investigator by relying on the clinical research coordinators to comply with all research requirements without sufficiently overseeing their day-to-day activities to ensure compliance. As corrective and preventive actions, you plan to participate with the new site management in the review of all studies for which you were the clinical investigator, and you plan to implement internal corrective action plans for future studies. You also stated that you attended mandatory training sessions related to, among other things, Good Clinical Practice for clinical trials. You further stated that you plan to develop and implement a system to determine at each subject's visit whether an SAE has occurred. You plan to use this system to receive notifications from other health care professionals if an SAE has occurred, and to notify the study sponsor and IRB when an SAE occurs, no more than 12 hours (or as provided by the applicable protocol) after becoming aware of its occurrence.
While we acknowledge the corrective and preventive actions that you have taken and plan to take, your response is inadequate because you have not provided sufficient details on how you, as a clinical investigator, will ensure adequate supervision and oversight of study personnel to whom you have delegated study procedures and tasks (for example, verifying that study activities performed by study personnel adhere to the protocol requirements), and how you plan to prevent similar violations from occurring in the future. You also did not provide sufficient details about how you will implement a system for reporting SAEs to ensure that the SAEs are reported in accordance with protocol requirements. Without these details, we are unable to determine whether your preventive action plan is adequate to prevent similar violations in the future.
We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data. Your failure to conduct the clinical investigation in accordance with the investigational plan, and specifically, your failure to report all SAEs to the sponsor within 24 hours of your knowledge of their occurrence, raises significant concerns about your protection of the study subjects enrolled at your site, and raises concerns about the reliability of the data collected at your site.
This letter is not intended to be an all-inclusive list of deficiencies with your clinical studies of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.
This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of receiving this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action without further notice to you. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.
Your written response, and any questions or concerns about this letter or the inspection, should be sent via email to the FDA at CDER-OSI-Communications@fda.hhs.gov.
Sincerely yours,
David C. Burrow, Pharm.D., J.D., Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
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Footnote:
1/ See Protocol (b)(4), Version 5, effective September 19, 2023. We note that Protocol (b)(4), Version 3, effective October 9, 2020, which was applicable during the occurrence of some of the SAEs included in this letter, stated that every SAE, regardless of causality, occurring after the subject has provided informed consent and until 16 weeks after the last dose of study drug, must be reported to (b)(4) safety within 24 hours of learning of its occurrence. However, we note that the regulatory violations exist regardless of which protocol version was in effect.
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/naseem-jaffrani-md-729750-05042026
Comptroller Statement on Proposed Revisions to the Uniform Financial Institutions Ratings System
WASHINGTON, May 20 -- The U.S. Department of the Treasury Office of the Comptroller of the Currency issued the following statement on May 19, 2026:
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Comptroller Statement on Proposed Revisions to the Uniform Financial Institutions Ratings System
Comptroller of the Currency Jonathan V. Gould issued the following statement today about the Federal Financial Institutions Examination Council's (FFIEC) proposed revisions to the Uniform Financial Institutions Rating System, commonly known as the CAMELS rating system.
I appreciate the collaborative efforts of the FFIEC and its member agencies
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WASHINGTON, May 20 -- The U.S. Department of the Treasury Office of the Comptroller of the Currency issued the following statement on May 19, 2026:
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Comptroller Statement on Proposed Revisions to the Uniform Financial Institutions Ratings System
Comptroller of the Currency Jonathan V. Gould issued the following statement today about the Federal Financial Institutions Examination Council's (FFIEC) proposed revisions to the Uniform Financial Institutions Rating System, commonly known as the CAMELS rating system.
I appreciate the collaborative efforts of the FFIEC and its member agenciesin developing the proposed revisions to the CAMELS ratings system. The revisions shift supervision away from process-heavy oversight toward a stronger focus on material financial risk. Modernizing CAMELS to more explicitly reflect material financial risks is a critical step to ensure our supervisory tools remain robust and responsive to the evolving banking landscape.
While I support the direction of this proposal, I remain concerned that the revisions do not sufficiently address "double counting" within the Management, or M, component. For the CAMELS framework to function effectively, each component must provide distinct, incremental value. Historically, the Management rating has reflected deficiencies already captured in other components. To maintain the integrity and transparency of the CAMELS system, it is vital that the Management rating serve as a standalone assessment rather than a secondary reflection of other components.
Furthermore, it is imperative that the financial institution regulators maintain a balanced and transparent supervisory perspective. Absent extenuating circumstances, no single component rating should disproportionately drive the composite rating. A bank's overall health is the sum of its parts, and the composite rating should be a transparent evaluation of all the factors rather than being driven by a single component.
I encourage commenters to pay close attention to these nuances during the comment period. We welcome feedback on how the framework can better distinguish between components to prevent overlapping assessments and ensure that the composite rating reflects a fair representation of a bank's risk profile.
Comments from the public are due 90 days from the date of publication of the proposed revisions in the Federal Register.
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Original text here: https://occ.gov/news-issuances/news-releases/2026/nr-occ-2026-39.html
