Saturday - April 19, 2025
*New Hampshire Editor Tipoffs Newsletter for Wednesday April 09, 2025 ( 14 items )  

As Trump Trade War Bludgeons US Economy, Administration Defunds Network of Centers That Boost American Manufacturing
WASHINGTON, April 9 -- Sen. Maria Cantwell, D-Washington, ranking member of the Senate Commerce, Science and Transportation Committee, issued the following news release on April 8, 2025: * * * As Trump Trade War Bludgeons US Economy, Administration Defunds Network of Centers That Boost American Manufacturing MEP Centers Created During '80's Trade War to Help Small American Manufacturers Survive and Thrive; Trump Action Undermines Decades of Investment in Manufacturing Resilience 15 Senators  more

FDA Affirms FLUMADINE Was Not Withdrawn Over Safety or Efficacy Concerns
WASHINGTON, April 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has concluded that FLUMADINE (rimantadine hydrochloride) 100 mg tablets, manufactured by Sun Pharmaceutical Industries Inc., were not withdrawn from the market due to safety or effectiveness issues. This decision clears the way for continued approval of generic versions of the antiviral drug, which had been discontinued for marketing but remains listed in the FDA's Orange Book under the "  more

FDA Affirms VIBRAMYCIN Oral Suspension Was Not Pulled Over Safety or Effectiveness
WASHINGTON, April 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has determined that VIBRAMYCIN (doxycycline) for oral suspension, equivalent to 25 mg base per 5 mL, was not removed from the market due to any safety or efficacy issues. The ruling, published in the Federal Register on April 9, 2025, ensures that the agency will continue approving abbreviated new drug applications referencing the discontinued product, provided those applications comply   more

FDA Concludes DECADRON Was Not Withdrawn for Safety or Effectiveness Reasons
WASHINGTON, April 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has announced that DECADRON (dexamethasone sodium phosphate) solution/drops, equivalent to 0.1 percent phosphate, was not pulled from the market due to safety or efficacy concerns. This decision clears the way for continued approval of generic versions of the drug, provided they comply with existing legal and regulatory standards. The determination, published in the Federal Register on A  more

FDA Finds ETHYOL Was Not Withdrawn for Safety or Effectiveness Reasons
WASHINGTON, April 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has confirmed that ETHYOL (amifostine) for injection, 500 milligrams per vial, was not removed from the market due to concerns about safety or effectiveness. This conclusion, published in the Federal Register on April 9, 2025, ensures that the agency will continue to approve generic versions of the drug as long as they meet legal and regulatory requirements under the abbreviated new drug  more

FDA Rules NASCOBAL Discontinued Voluntarily, Not Due to Safety or Effectiveness Concerns
WASHINGTON, April 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has confirmed that NASCOBAL (cyanocobalamin) nasal spray, 0.5 mg per spray, was not removed from the market due to safety or efficacy concerns. This ruling, issued on April 9, 2025, enables the agency to continue approving abbreviated new drug applications (ANDAs) that reference NASCOBAL, as long as those applications meet existing legal and regulatory standards. The product was original  more

FDA Seeks Input on Adopting JSON-Based Format for Electronic Study Data Submissions
WASHINGTON, April 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a formal request for public comment as it evaluates a potential shift in the electronic submission of clinical study data to a more modern, streamlined format. In a notice published in the Federal Register on April 9, the Agency proposed the possible adoption of the Clinical Data Interchange Standards Consortium (CDISC) Dataset-JavaScript Object Notation (Dataset-JSON) version  more

FDA Seeks Public Comment on Annual Susceptibility Test Criteria Update Under 21st Century Cures Act
WASHINGTON, April 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued its annual notice compiling updates to its Susceptibility Test Interpretive Criteria (STIC) web page, inviting public feedback in accordance with mandates under the 21st Century Cures Act. Published in the Federal Register on April 9, 2025, the notice outlines revisions made throughout 2024 to FDA-recognized standards used in antimicrobial susceptibility testing, a cornerstone   more

FDA Withdraws Approval of 18 Drug Applications Including GE HealthCare, Pfizer, AbbVie, and Others
WASHINGTON, April 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration announced the formal withdrawal of approval for 18 new drug applications (NDAs) from several pharmaceutical manufacturers, including GE HealthCare, Pfizer Inc., AbbVie Inc., Janssen Pharmaceuticals, and others. The move comes after the companies voluntarily informed the agency that the drug products are no longer being marketed and requested the termination of their applications. The with  more

N.H. Environmental Services Dept.: More Than $7.5 Million Available for Aquatic Resource Restoration
CONCORD, New Hampshire, April 8 -- The New Hampshire Department of Environmental Services issued the following news release on April 7, 2025: * * * More Than $7.5 Million Available for Aquatic Resource Restoration Concord, NH -The New Hampshire Department of Environmental Services' (NHDES) Aquatic Resource Mitigation (ARM) Fund is now accepting pre-proposals for its 2025 grant round. The ARM Fund Program ensures that funds generated through In-Lieu Fee (ILF) mitigation payments for unavoidabl  more

N.H. Gov. Ayotte Celebrates Groundbreaking of New NH 911 Facility in Laconia
CONCORD, New Hampshire, April 8 -- Gov. Kelly Ayotte, R-New Hampshire, issued the following news release on April 7, 2025: * * * Governor Ayotte Celebrates Groundbreaking of New NH 911 Facility in Laconia CONCORD, NH - Today, Governor Kelly Ayotte joined state officials, public safety leaders, and emergency personnel to break ground on New Hampshire 911's new call center in Laconia. "Our state has the best 911 professionals in the country," said Governor Kelly Ayotte. "This new facility in L  more

Ranking Member Shaheen Remarks at Hearing for Nominees for Ambassador to the Vatican, Chile and Croatia
WASHINGTON, April 9 -- Sen. Jeanne Shaheen, D-New Hampshire, ranking member of the Senate Foreign Relations Committee, issued the following news release on April 8, 2025: * * * Ranking Member Shaheen Remarks at Hearing for Nominees for Ambassador to the Vatican, Chile and Croatia WASHINGTON - Today, U.S. Senator Jeanne Shaheen (D-NH), Ranking Member of the Senate Foreign Relations Committee, delivered opening remarks at the hearing on the nominations of Brian Burch to be Ambassador to the Vat  more

Senator Collins Urges Administration to Support Maine Fire Departments Harmed by Tariffs
WASHINGTON, April 8 -- Sen. Susan M. Collins, R-Maine, issued the following news release: * * * Senator Collins Urges Administration to Support Maine Fire Departments Harmed by Tariffs Washington, D.C. - U.S. Senator Susan Collins sent a letter to Department of Commerce Secretary Howard Lutnick and U.S. Trade Representative Jamieson Greer, urging the Administration to address the hardship that tariffs will impose on fire departments and businesses in Maine, particularly the tariffs imposed on  more

Shaheen, Murkowski Seek Immediate Explanation for Department of Homeland Security's Erroneous and Threatening Email to Ukrainians in the United States
WASHINGTON, April 7 -- Sen. Jeanne Shaheen, D-New Hampshire, issued the following news release: * * * Shaheen, Murkowski Seek Immediate Explanation for Department of Homeland Security's Erroneous and Threatening Email to Ukrainians in the United States (Washington, DC) - U.S. Senators Jeanne Shaheen (D-NH), Ranking Member of the U.S. Senate Foreign Relations Committee, and Lisa Murkowski (R-AK) sent a letter to Homeland Security Secretary Kristi Noem yesterday seeking answers following report  more