WASHINGTON, Dec. 25 (TNSFR) -- The Food and Drug Administration (FDA) has issued a final rule to establish requirements for nonprescription drug products with an additional condition for nonprescription use (ACNU). This regulatory framework enables certain drugs, previously requiring a prescription, to be marketed without one if specific conditions are met to ensure safe and effective use by consumers. The new rule aims to expand consumer access to safe and effective medications, potentially im  more

WASHINGTON, Dec. 24 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Rontis Hellas S.A.: * * * To: Ms. Efi Soultou, CEO, Rontis Hellas S.A., Industrial Area of Larissa Larissa, 415 00 Thessaloniki, Greece Dear Ms. Efi Soultou, During an inspection of your firm located in Larissa, Thessaloniki, 415 00 Greece on July 22, 2024 through July 25, 2024, an investigator from the United States Food and Drug Administration (FDA) de  more

WASHINGTON, Dec. 24 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Anne's Daye Ltd dba Tampon Innovations: * * * To: Valentina Milanova, Founder & CEO, Anne's Daye Ltd dba Tampon Innovations, The Biscuit Factory, 100 Drummond Road, Bermondsey, London SE16 4DG, United Kingdom Dear Valentina Milanova: During an inspection of your firm located in Oblast Sofia Grad, Bulgaria on July 8, 2024, through July 11, 2024, an invest  more

WASHINGTON, Dec. 26 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Dec. 20, 2024, from the American Association for Laboratory Accreditation: * * * To: Mr. Eric Franca Center for Devices and Radiological Health, Food and Drug Administration 10903 New Hampshire Ave., Building 66, Rm. 5500 Silver Spring, MD 20993-0002 Docket ID: FDA-2019-D-3805-0075 * * * Dear Mr. Franca, On behalf of the American Ass  more

WASHINGTON, Dec. 26 -- The U.S. Department of Health and Human Services Food and Drug Administration has released the following public communication dated Dec. 17, 2024, 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-2052; Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice * * * The Biotechnology Innovation Organiza  more

WASHINGTON, Dec. 25 (TNSFR) -- The Food and Drug Administration (FDA) has announced a reorganization of its Center for Drug Evaluation and Research (CDER) to streamline operations and enhance its ability to ensure medication safety. The changes, which were approved in November 2014, aim to better position the FDA to address critical public health priorities. "The purpose of this reorganization is to strengthen OSE and OND's ability to support FDA's mission and streamline its operations," the FD  more

WASHINGTON, Dec. 26 -- The U.S. Department of Labor Wage and Hour Division has released the following public communication dated Dec. 10, 2024, from the National Organization on Disability: * * * To: Division of Regulations, Legislation, and Interpretation Wage and Hour Division U.S. Department of Labor Room S-3502 200 Constitution Avenue, N.W Washington, DC 20210 RE: Comments in response to Proposed Rule: Employment of Workers with Disabilities under Section 14(c) of the Fair Labor Stan  more

CONCORD, New Hampshire, Dec. 24 -- The New Hampshire Public Utilities Commission issued the following order (No. DW 24-109) involving Nancy Monks: * * * Petition Appealing New Hampshire Department of Energy's Final Decision on Complaint No. CPT 2024-006 Against Pennichuck Water Works, Inc. SUPPLEMENTAL ORDER OF NOTICE On November 1, 2024, the petitioner, Nancy Monks, filed a petition contesting the New Hampshire Department of Energy's (DOE) decision on her complaint against Pennichuck Water   more

WASHINGTON, Dec. 27 -- The Senate Homeland Security and Governmental Affairs Committee released the following written testimony by Louis DeJoy, postmaster general and CEO of the U.S. Postal Service, from a Dec. 5, 2024, hearing entitled "Oversight of the United States Postal Service: Understanding Proposed Service Changes": * * * (Continued from Part 2 of 3) Growth and cost reduction are at the heart of the DFA plan. Simply put, the DFA plan is not about contraction or only cost reduction. Th  more