Consistent with the agency’s obligations under the SUPPORT for Patients and Communities Act (SUPPORT Act), the Breakthrough Devices Program may be available for certain non-addictive medical products to treat pain or addiction. This guidance updates the previous version of the guidance, of the same title, issued on December 18, 2018, and describes how the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities. The document describes policies that FDA intends to use to implement a section of the FD&C Act. On September 14, 2023, FDA issued final guidance entitled, Breakthrough Devices Program.FDA announced the establishment of a docket to solicit comments that will assist the agency in developing a Quality Management Maturity (QMM) program for establishments manufacturing human drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER). On September 14, 2023, the FDA issued a notice of establishment of a public docket entitled, Quality Management Maturity Program for Drug Manufacturing Establishments.Thus, the agency will not accept or approve abbreviated new drug applications (ANDAs) for Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg. FDA determined that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. On September 12, 2023, FDA issued a notice entitled, Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn from Sale for Reasons of Safety or Effectiveness.
This notice publishes the OMOR fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMOR). On September 11, 2023, the Food and Drug Administration (FDA) issued guidance entitled, Over-the-Counter Monograph Drug User Fee Program-OTC Monograph Order Requests Fee Rates for Fiscal Year 2024.Senators Bernie Sanders (I-VT) and Roger Marshall (R-KS) released a new draft health bill, the “Bipartisan Primary Care and Health Workforce Act,” and CMS announced Medicare beneficiary copays for 34 prescription drugs may be lower between October and December 2023. Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance federal legislation and congressional committee action reports, studies, and analyses and other health policy news.
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