SILVER SPRING, Md., July 30, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: nnToday, the FDA is announcing the fiscal year (FY) 2025 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP). The user fee rates are authorized by the FDA Food Safety Modernization Act (FSMA) and allow the agency to assess and collect fees to cover the FDA's cost of administering these programs.
908 Devices Appoints Michele M. Leonhart, Former Administrator of the United States Drug Enforcement Administration (DEA), to Its Board of Directors
June 14 (Reuters) - The U.S. Food and Drug Administration said on Friday that Merit Medical Systems (MMSI.O), opens new tab has initiated a recall for unapproved plastic syringes supplied by China-based Jiangsu Shenli Medical Production.
U.S. Food and Drug Administration Approves Augtyro™ (repotrectinib), a Next-Generation Tyrosine Kinase Inhibitor (TKI), for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors
CRANBURY, N.J., May 2, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the investigational new drug (IND) application for the use of bremelanotide, a melanocortin receptor 4 agonist (MCR4), for the treatment of obesity. The Company is cleared to begin enrollment in a Phase 2 clinical study evaluating the safety and efficacy of bremelanotide, co-administered with tirzepatide (GLP1/GIP) in obese patients. The Phase 2 clinical study is expected to start mid-calendar year 2024, with topline data results by the end of calendar year 2024.
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