Thursday - May 22, 2025
*New Hampshire Editor Tipoffs Newsletter for Wednesday April 23, 2025 ( 19 items )  

As Trump Pushes Toward Recession, Heinrich & Lujan Demand Answers on Cuts to New Mexico Manufacturing Center
WASHINGTON, April 22 -- Sen. Ben Ray Lujan, D-New Mexico, issued the following news release: * * * As Trump Pushes Toward Recession, Heinrich & Lujan Demand Answers on Cuts to New Mexico Manufacturing Center WASHINGTON -- U.S. Senator Martin Heinrich and Ben Ray Lujan (D-N.M.) are demanding answers on the Administration's decision to cancel funding for ten National Institute of Standards and Technology Hollings Manufacturing Extension Partnership (MEP) Centers across the country, including in  more

FDA Announces Continuation of Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
WASHINGTON, April 23 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) announced the continuation of the voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for the second year. The program, which is managed by the Center for Drug Evaluation and Research (CDER), aims to enhance the quality management practices within drug manufacturing establishments. These practices are designed to prioritize patient safety,  more

FDA Approves Eylea Hd (Aflibercept) Under Material Threat MCM Priority Review Voucher
WASHINGTON, April 23 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) announced the approval of EYLEA HD (aflibercept) for the treatment of certain retinal diseases, redeeming a priority review voucher. The approval, which was granted on August 18, 2023, for the expanded formulation of the anti-VEGF (vascular endothelial growth factor) drug, EYLEA, was issued in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). This marks the suc  more

FDA Awards Priority Review Voucher for Ebanga (Ansuvimab-Zykl) to Ridgeback Biotherapeutics
WASHINGTON, April 23 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) announced the issuance of a priority review voucher to Ridgeback Biotherapeutics, LP, for its material threat medical countermeasure (MCM) product, EBANGA (ansuvimab-zykl) for injection. The voucher was awarded following the product's approval for treating infections caused by the Zaire ebolavirus in both adult and pediatric patients, including neonates born to mothers who are RT  more

FDA Issues Warning Letter to Hoosierecig.com
WASHINGTON, April 23 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to hoosierecig.com: * * * To: hoosierecig.com, 1030 N. Lincoln Street, Suite 1800, Greensburg, IN 47240, United States, hoosierecig@gmail.com, hoosiereciginc@gmail.com To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://www.hoosierecig.com and determined that electroni  more

FDA Releases Public Communication From Biotechnology Innovation Organization
WASHINGTON, April 23 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated April 4, 2025, from the Biotechnology Innovation Organization: * * * To: U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Re: Docket No. FDA-2024-D-4689; Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products * * * Dear Recipient:  more

FDA Releases Public Communication From Cochlear Americas Regulatory Affairs Director Blair
WASHINGTON, April 23 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated April 4, 2025, from Laura Blair, regulatory affairs director at Cochlear Americas, Lone Tree, Colorado: * * * To: Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 RE: Docket Number FDA-2024-D-4488, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission   more

FDA Seeks Public Input on Exploring Health Level Seven Fast Healthcare Interoperability Resources for Real-World Data Submission
WASHINGTON, April 23 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has established a public docket to explore the potential use of Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) in clinical studies involving real-world data (RWD). This initiative is designed to facilitate the submission of structured and standardized data collected from various RWD sources, including electronic health records (EHRs), medical claims data, an  more

Justice Department Announces Membership Change in Expeditionary Missions Consortium-Crane
WASHINGTON, April 23 (TNSFR) -- The U.S. Department of Justice Antitrust Division has announced that the Expeditionary Missions Consortium-Crane (EMC2) has submitted updated membership information in accordance with Section 6(a) of the National Cooperative Research and Production Act of 1993. The notification, published in the Federal Register on April 23, 2025, outlines recent changes to the consortium's roster of participating organizations and continues the process that limits the liability   more

Markey, Pressley, Warren Demand Answers About Trump Administration's Gross Misconduct of Immigration Enforcement System
WASHINGTON, April 22 -- Sen. Edward J. Markey, D-Massachusetts, issued the following news release: * * * Markey, Pressley, Warren Demand Answers About Trump Administration's Gross Misconduct of Immigration Enforcement System Letter Text (PDF) Boston (April 22, 2025) - Senator Edward J. Markey (D-Mass.), Representative Ayanna Pressley (MA-07), and Senator Elizabeth Warren (D-Mass.) wrote today to Secretary of Homeland Security Kristi Noem and U.S. Immigration and Customs Enforcement (ICE) Ac  more

N.H. Environmental Services Dept.: $5.1 Million in Grant Funding Available in Granite State Clean Fleets Program
CONCORD, New Hampshire, April 23 -- The New Hampshire Department of Environmental Services issued the following news release on April 22, 2025: * * * $5.1 Million in Grant Funding Available in Granite State Clean Fleets Program The New Hampshire Department of Environmental Services (NHDES) Mobile Sources Section has opened a new $5.1 million Request for Proposals (RFP) through the Granite State Clean Fleets (GSCF) program. GSCF is a competitive reimbursement program for public and private en  more

N.H. Gov. Ayotte Directs Flags to Half-Staff in Accordance With President's Proclamation
CONCORD, New Hampshire, April 23 -- Gov. Kelly Ayotte, R-New Hampshire, issued the following news release on April 22, 2025: * * * Governor Ayotte Directs Flags to Half-Staff in Accordance with President's Proclamation CONCORD, NH - Today, in accordance with the President's proclamation, Governor Kelly Ayotte has directed all flags on public buildings and grounds in the State of New Hampshire to be lowered to half-staff in remembrance of Pope Francis, and remain at half-staff until sunset on   more

Pappas, Letlow, Kean Reintroduce Bipartisan Legislation to Help Small, Rural Departments Upgrade Essential Public Safety Infrastructure
WASHINGTON, April 21 -- Rep. Chris Pappas, D-New Hampshire, issued the following news release: * * * Pappas, Letlow, Kean Reintroduce Bipartisan Legislation to Help Small, Rural Departments Upgrade Essential Public Safety Infrastructure Legislation would authorize new building grant programs to help small jurisdictions make needed infrastructure upgrades. Today Congressman Chris Pappas (NH-01), Congresswoman Julia Letlow (LA-05), and Congressman Tom Kean Jr. (NJ-07) reintroduced the Buildin  more

Pressley, Markey, Warren Demand Answers About Trump Administration's Gross Misconduct of Immigration Enforcement System
WASHINGTON, April 22 -- Rep. Ayanna Pressley, D-Massachusetts, issued the following news: * * * Pressley, Markey, Warren Demand Answers About Trump Administration's Gross Misconduct of Immigration Enforcement System Following the Abduction and Detention of Rumeysa Ozturk, Pressley, Markey, and Warren Sound the Alarm on the Trump Administration's Unjust Deportation Agenda Text of Letter (PDF) WASHINGTON - Congresswoman Ayanna Pressley (MA-07) and Senators Edward J. Markey (D-MA) and Elizab  more

Ranking Member Shaheen Statement on the Reorganization of the State Department
WASHINGTON, April 23 -- Sen. Jeanne Shaheen, D-New Hampshire, ranking member of the Senate Foreign Relations Committee, issued the following news release on April 22, 2025: * * * Ranking Member Shaheen Statement on the Reorganization of the State Department WASHINGTON - Today, U.S. Senator Jeanne Shaheen (D-NH), Ranking Member of the Senate Foreign Relations Committee, issued the following statement on the reorganization of the U.S. State Department: "Any changes to the State Department and   more

Ranking Member Shaheen Urges Administration to Remove Barriers to Engagement With Syrian Interim Government
WASHINGTON, April 23 -- Sen. Jeanne Shaheen, D-New Hampshire, ranking member of the Senate Foreign Relations Committee, issued the following news release on April 22, 2025: * * * Ranking Member Shaheen Urges Administration to Remove Barriers to Engagement with Syrian Interim Government WASHINGTON - This week, U.S. Senator Jeanne Shaheen (D-NH), Ranking Member of the Senate Foreign Relations Committee, sent a letter to Secretary of State Marco Rubio and Secretary of the Treasury Scott Bessent   more

Senator Hassan Calls Out HHS Secretary Kennedy for Hiring Fraudster to Relitigate Long-Disproven Theories
WASHINGTON, April 22 -- Sen. Maggie Hassan, D-New Hampshire, issued the following news release: * * * Senator Hassan Calls Out HHS Secretary Kennedy for Hiring Fraudster to Relitigate Long-Disproven Theories WASHINGTON - U.S. Senator Maggie Hassan (D-NH) is calling out Health and Human Services Secretary Robert F. Kennedy, Jr.'s reported decision to hire David Geier, an individual with a history of practicing medicine without a license, to relitigate long-disproven links between vaccines and   more

Senator Hassan Helps Reintroduce Bill to Support Children with Disabilities
WASHINGTON, April 22 -- Sen. Maggie Hassan, D-New Hampshire, issued the following news release: * * * Senator Hassan Helps Reintroduce Bill to Support Children with Disabilities WASHINGTON - U.S. Senator Maggie Hassan (D-NH) helped reintroduce the IDEA Full Funding Act, legislation to ensure that Congress finally fulfills its commitment to fully fund 40 percent of costs under the Individuals with Disabilities Education Act ( IDEA ). Fifty years ago, Congress passed IDEA to ensure that every c  more

Senators Introduce Bipartisan New England Offshore Drilling Ban
WASHINGTON, April 22 -- Sen. Maggie Hassan, D-New Hampshire, issued the following news release: * * * Senators Introduce Bipartisan New England Offshore Drilling Ban Washington, DC - On Earth Day, a bipartisan group of New England Senators is announcing the introduction of legislation to bar offshore drilling along the New England coast. The New England Coastal Protection Act is cosponsored by Senators Sheldon Whitehouse (D-RI), Richard Blumenthal (D-CT), Susan Collins (R-ME), Maggie Hassan (  more