WASHINGTON, Dec. 9 (Rep.) -- The Congressional Western Caucus issued the following news release: * * * Chairman LaMalfa Leads House in Renewing Secure Rural Schools Payments * Washington, D.C. Today, Congressional Western Caucus Chairman Doug LaMalfa (CA-01) led the effort in the House of Representatives to pass the Secure Rural Schools Reauthorization Act of 2025, which reauthorizes Secure Rural Schools (SRS) payments to rural counties in Northern California and across the country. This leg  more

WASHINGTON, Dec. 9 (TNSFR) -- The U.S. Department of Transportation Federal Railroad Administration has issued a notice informing the public that the American Short Line and Regional Railroad Association (ASLRRA) has submitted a petition to amend an existing waiver. This proposed amendment relates to regulations governing the hours of service for railroad employees. The ASLRRA specifically seeks to add six railroads to the list of participants already covered by the original waiver. This waive  more

WASHINGTON, Dec. 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has finalized its determination of the regulatory review period for the human drug product Filsuvez, also known as birch triterpenes. This determination is a required step following the submission of applications to the director of the Patent and Trademark Office for the extension of patents claiming the drug. Filsuvez is indicated for the treatment of wounds associated with dystrophic   more

WASHINGTON, Dec. 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has announced the availability of a final guidance document to address questions about promotional labeling and advertising for prescription biological products. This guidance entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers" applies to manufact  more

WASHINGTON, Dec. 10 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to elfbarvapesusa.com from the Center for Tobacco Products: * * * Recipient: elfbarvapesusa.com, United States, sales@elfbarvapesusa.com Issuing Office: Center for Tobacco Products, United States WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://elfb  more

WASHINGTON, Dec. 10 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to KMT Distribution LLC from the Center for Tobacco Products: * * * Recipient: KMT Distribution LLC, 6690 Sterling Drive North, Sterling Heights, MI 48312, United States Issuing Office: Center for Tobacco Products, United States WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently r  more

WASHINGTON, Dec. 10 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to onlinevapeshop.us from the Center for Tobacco Products: * * * Recipient: onlinevapeshop.us, 10655 Richmond Ave Ste 130A, Houston, TX 77042, United States, info@onlinevapeshop.us, blackcoraltexas@gmail.com Issuing Office: Center for Tobacco Products, United States WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food a  more

WASHINGTON, Dec. 10 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Lux Therapeutics LLC dba Ponya Therapeutics LLC from the Office of Compliance and Biologics Quality: * * * Recipient: Mekonnen Abebe, Owner and Chief Executive Officer, Lux Therapeutics LLC dba Ponya Therapeutics LLC, 13 Corporate Blvd NE, Brookhaven, GA 30329, United States, MAbebe@ponyadx.com Issuing Office: Office of Compliance and Biologics Quality, U  more

WASHINGTON, Dec. 10 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to The Vape Shop from the Center for Tobacco Products: * * * Recipient: The Vape Shop, 2680 Ridge Road West, Suite 103, Rochester, NY 14626, United States Issuing Office: Center for Tobacco Products, United States WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed our ins  more

WASHINGTON, Dec. 10 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to virginiavapes.com from the Center for Tobacco Products: * * * Recipient: virginiavapes.com, 18059 Triangle Shopping Plaza, Dumfries, VA 22026, United States, contact@virginiavapes.com Issuing Office: Center for Tobacco Products, United States WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration  more

WASHINGTON, Dec. 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has announced the availability of additional draft and revised draft product-specific guidances for the industry. These documents offer recommendations on the design of bioequivalence (BE) studies, which are crucial components for supporting abbreviated drug applications (ANDAs) seeking approval for generic drug products. This action follows the process outlined in a June 11, 2010, Federa  more

WASHINGTON, Dec. 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has announced the availability of a draft guidance that offers recommendations for streamlined nonclinical safety studies for certain drug development products. The guidance entitled "Monoclonal Antibodies: Streamlined Nonclinical Safety Studies" focuses on monospecific antibodies, which are products that recognize a single molecular target. The document provides approaches intended to a  more

WASHINGTON, Dec. 9 -- Sen. Jeanne Shaheen, D-New Hampshire, issued the following news release: * * * New Hampshire Delegation Welcomes More than $9 Million for Granite State Projects Through Northern Border Regional Commission * (Washington, DC) - Today, U.S. Senator Jeanne Shaheen (D-NH), a senior member of the U.S. Senate Appropriations Committee, and U.S. Senator Maggie Hassan (D-NH), alongside U.S. Representatives Chris Pappas (NH-01) and Maggie Goodlander (NH-02), welcomed more than $9   more

WASHINGTON, Dec. 8 -- Rep. Chris Pappas, D-New Hampshire, issued the following news release: * * * NH Delegation Welcomes More than $9 Million for Granite State Projects Through Northern Border Regional Commission * Today Congressman Chris Pappas (NH-01) joined Senator Jeanne Shaheen (D-NH), a senior member of the U.S. Senate Appropriations Committee, and Senator Maggie Hassan (D-NH), and Congresswoman Maggie Goodlander (NH-02) in welcoming more than $9 million in federal funding for Granite  more

WASHINGTON, Dec. 9 -- Sen. Peter Welch, D-Vermont, issued the following news release: * * * Sanders, Welch, Balint, and Scott Announce More Than $12 Million in Northern Border Regional Commission Investments for Vermont Communities * MONTPELIER, VT - The Vermont Congressional Delegation, Senators Bernie Sanders (I-Vt.), Peter Welch (D-Vt.), and Representative Becca Balint (VT-At Large), along with Governor Phil Scott and the Northern Border Regional Commission (NBRC), announced NBRC's Fall 2  more

WASHINGTON, Dec. 10 -- Sen. Maggie Hassan, D-New Hampshire, ranking member of the Joint Economic Committee, issued the following news release on Dec. 9, 2025: * * * Senator Hassan Presses Corporate Owners of Mobile Home Communities for Answers on Affordability and Resident Living Conditions Today, U.S. Senator Maggie Hassan (D-NH), Ranking Member of the Joint Economic Committee, pressed six corporate owners of manufactured housing communities for answers on affordability and living conditions  more

WASHINGTON, Dec. 9 -- Sen. Susan M. Collins, R-Maine, issued the following news release: * * * Senators Collins, King Announce More Than $6.5 Million for Economic Development Projects Across Maine * WASHINGTON, D.C. - U.S. Senators Susan CollinsChair of the Senate Appropriations Committeeand Angus King announced that 10 Maine organizations will receive a total of $6,541,337 to support important development projects. The funding comes from the Northern Border Regional Commission's (NBRC) Fisc  more

WASHINGTON, Dec. 9 -- Sen. Angus S. King Jr., I-Maine, issued the following news release: * * * Senators Collins, King Announce More Than $6.5 Million for Economic Development Projects Across Maine * WASHINGTON, D.C. - U.S. Senators Susan CollinsChair of the Senate Appropriations Committeeand Angus King announced that 10 Maine organizations will receive a total of $6,541,337 to support important development projects. The funding comes from the Northern Border Regional Commission's (NBRC) Fis  more