WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has announced the availability of a new draft guidance aimed at helping healthcare establishments determine the eligibility of donors for human cells, tissues, and cellular and tissue-based products (HCT/Ps). This updated document provides general recommendations and clarifies various aspects of donor screening, medical history interviews, and testing protocols to ensure the safety of these products. The draft guidance also o  more

WASHINGTON, Jan. 7 (TNSFR) -- The U.S. Food and Drug Administration (FDA) has released a draft guidance document aimed at improving the evaluation of sex- and gender-specific data in medical device clinical studies. The draft guidance encourages medical device developers to consider sex and gender factors in clinical investigations to ensure the safety and effectiveness of devices across diverse populations. This document also addresses the historical underrepresentation of women and other gend  more

WASHINGTON, Jan. 7 (TNSFR) -- The U.S. Food and Drug Administration (FDA) has made available a draft guidance for industry titled "Study of Sex Differences in the Clinical Evaluation of Medical Products." The guidance highlights the importance of including sufficient numbers of both males and females in clinical trials and non-interventional studies to reflect the prevalence of diseases and conditions that medical products aim to treat. The goal is to better understand potential sex-specific d  more

WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has announced the immediate availability of a final guidance aimed at reducing the risk of transmission of disease agents associated with sepsis by human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance provides recommendations for establishments involved in donor eligibility determinations, focusing on the clinical screening of potential donors for signs of sepsis. The FDA highlights that this up  more

WASHINGTON, Jan. 7 (TNSFR) -- The U.S. Food and Drug Administration (FDA) has finalized its guidance for the tobacco industry on the "Validation and Verification of Analytical Testing Methods Used for Tobacco Products." This finalized guidance provides essential information and recommendations to assist tobacco product manufacturers in generating reliable and consistent data to support regulatory submissions, including those related to the ingredients, constituents, and additives in tobacco prod  more

WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has announced the availability of its final guidance regarding the notification process for the permanent discontinuance or interruption in the manufacturing of medical devices under Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This updated guidance, published on January 7, 2025, builds upon the previously issued version from November 2023, alongside finalizing a set of updates related to the 506J Devic  more

WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has released a draft guidance titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway." This document addresses the agency's interpretation of confirmatory trials mandated under the accelerated approval process for drugs. These trials are critical for verifying the clinical benefits or effects of such drugs on irreversible morbidity or mortality. The draft outlines the factors   more

WASHINGTON, Jan. 7 (TNSFR) -- The U.S. Food and Drug Administration (FDA) has released draft guidance detailing recommendations for the lifecycle management and marketing submissions of artificial intelligence (AI)-enabled device software functions. The guidance outlines the agency's expectations regarding documentation and information necessary to evaluate the safety and effectiveness of such devices. It emphasizes a Total Product Lifecycle (TPLC) approach, encouraging sponsors to integrate c  more

WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has released a draft guidance document addressing pulse oximeters for medical purposes. This document offers recommendations for non-clinical and clinical performance testing, labeling, and premarket submissions for devices that estimate arterial blood oxygen levels and pulse rates. The guidance also highlights concerns regarding the accuracy of these devices, particularly how skin pigmentation can impact their performance. T  more

WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has unveiled a draft guidance for the use of artificial intelligence (AI) in regulatory decision-making concerning drug and biological products. This document provides recommendations to industry stakeholders on how AI-generated data can support regulatory determinations about safety, effectiveness, and quality. Developed in collaboration with multiple FDA centers, the draft emphasizes a risk-based credibility assessment fram  more

WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has announced the availability of final guidance for industry titled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This new policy finalizes the draft issued in December 2023 and replaces the guidance published in January 2017. It specifically pertains to human drug product compounding by licensed pharmacists or physicians, allowing the use of bulk d  more

WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued a draft guidance document titled "Considerations for Including Tissue Biopsies in Clinical Trials." This guidance is designed to aid industry professionals, clinical investigators, institutions, and institutional review boards (IRBs) in understanding best practices for conducting tissue biopsies in adults and children participating in clinical trials. The recomm  more

WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has announced the availability of three draft guidelines aimed at reducing the transmission risks of hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) through human cells, tissues, and cellular and tissue-based products (HCT/Ps). These guidelines update prior recommendations to help tissue donation establishments comply with donor eligibility requirements, which include screening and tes  more

WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has announced the availability of a final guidance document for the pharmaceutical industry regarding compounding practices using bulk drug substances. The guidance, titled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act," outlines the interim regulatory stance the FDA will take while developing the official list of bulk drug substances suitable for comp  more

WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has issued new guidance aimed at reducing the risk of tuberculosis (TB) transmission through human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance provides recommendations for establishments involved in donor eligibility determinations to screen for Mycobacterium tuberculosis (Mtb), the bacterium responsible for TB. It also advises these establishments on additional precautionary measures to take  more

WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has released a draft guidance outlining recommendations for validating in vitro diagnostic devices (IVDs) used to detect emerging pathogens during public health emergencies. The draft guidance, titled "Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency," addresses test data and information required for the approval of tests submitted under the Emergency Use Authoriza  more

CONCORD, New Hampshire, Jan. 7 -- New Hampshire Attorney General John Formella issued the following news release on Jan. 6, 2025: Attorney General John M. Formella announces the resolution of an Attorney General's Office review of the proposed acquisition of Catholic Medical Center ("CMC") by Manchester Health Services, LLC, a subsidiary of HCA Healthcare, Inc. ("HCA"). The statutory review, conducted separately by both the Attorney General's Charitable Trusts Unit and the AG's Consumer Protect  more

BEDFORD, New Hampshire, Jan. 7 -- The New Hampshire Housing Finance Authority issued the following news: New Hampshire Housing announces the launch of the Opioid Use Disorder Supportive Housing Capital Program, a new initiative aimed at providing stable housing for individuals and families impacted by opioid use disorder and co-occurring disorders. The Notice of Funding Opportunity (NOFO) for this program was released on January 6, 2025, and applications must be submitted by March 11, 2025. T  more

CONCORD, New Hampshire, Jan. 7 -- The office of the U.S. Attorney for the District of New Hampshire issued the following news release: United States Attorney Jane E. Young announces the appointment of Assistant United States Attorney (AUSA) John Kennedy as the Deputy Chief of the Criminal Division, the internal transfers of AUSA Kasey Weiland to the Civil Division and AUSA Matthew Vicinanzo to the Criminal Division, and the creation of an External Engagement Division at the United States Attorn  more

CONCORD, New Hampshire, Jan. 7 -- The office of the U.S. Attorney for the District of New Hampshire issued the following news release: A Laconia man pleaded guilty in federal court in connection with his distribution of methamphetamine and his possession of a firearm as a prohibited person, Attorney Jane E. Young announces. Steven Ridgeway, 50, pleaded guilty to two counts of distribution of methamphetamine and one count of possession of a firearm by a prohibited person. U.S. District Court Ju  more

CONCORD, New Hampshire, Jan. 7 -- The office of the U.S. Attorney for the District of New Hampshire issued the following news release: A Massachusetts man was sentenced today in federal court for his role in an organization trafficking drugs into New Hampshire, U.S. Attorney Jane E. Young announces. Osvaldo Soto Jimenez, age 30, was sentenced by U.S. District Court Judge Samantha Elliott to 46 months in federal prison and 3 years of supervised release. In August 2024, Soto Jimenez pleaded guil  more

WASHINGTON, Jan. 7 -- Sen. Jeanne Shaheen, D-New Hampshire, ranking member of the Senate Foreign Relations Committee, issued the following news release on Jan. 6, 2025: Today, U.S. Senator Jeanne Shaheen (D-NH), Ranking Member of the Senate Foreign Relations Committee, expressed her gratitude to Canadian Prime Minister Justin Trudeau for his leadership and close cooperation with the United States following his announcement that he intends to resign as Liberal leader. "I thank Prime Minister Ju  more

WASHINGTON, Jan. 6 -- Sen. Jeanne Shaheen, D-New Hampshire, issued the following news release: Senator Jeanne Shaheen (D-NH) released the following statement on the certification of the results of the 2024 presidential election: "Upholding the peaceful transition of power is a fundamental responsibility for Congress. Today's certification of the election results is the American way. The violent, un-American attack we witnessed four years ago on the U.S. Capitol attempting to stop the vote must  more

WASHINGTON, Jan. 6 -- Sen. Jeanne Shaheen, D-New Hampshire, issued the following news release: (Washington, DC) - U.S. Senator Jeanne Shaheen (D-NH) released the following statement on the certification of the results of the 2024 presidential election: "Upholding the peaceful transition of power is a fundamental responsibility for Congress. Today's certification of the election results is the American way. The violent, un-American attack we witnessed four years ago on the U.S. Capitol attempt  more

WASHINGTON, Jan. 7 -- Sen. Jack Reed, D-Rhode Island, issued the following news release: NEWPORT, RI - No, Rhode Island is not pregnant. But the Ocean State will soon be giving 'berth' to two sets of 360-foot twin U.S. Coast Guard (USGC) Offshore Patrol Cutters (OPCs) that weigh in at about 4,500 long tons when fully loaded. The Heritage-class vessels will each have room onboard for 100-plus crewmembers. The four sister ships will eventually replace the two 270-foot medium endurance cutters s  more

WASHINGTON, Jan. 7 -- The U.S. Department of Agriculture issued the following news release: Jan. 7, 2025 Today, the U.S. Department of Agriculture (USDA) announced the appointment of 36 members to serve on the newly formed Greenhouse Gas Technical Assistance Provider and Third-Party Verifier Program Advisory Council, informally referred to as to the Growing Climate Solutions Act Advisory Council. The council will support the Greenhouse Gas Technical Assistance Provider and Third-Party Verifie  more