• where experts go to learn about FDA
  • Month: April 2024

    • Does the Drug Shortage White Paper Fall Short?April 9th, 2024

      The U.S. Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States—with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and …

    • OPQ’s 2023 Annual Report: an Upbeat Review of CDER’s Quality EffortsApril 8th, 2024

      CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. Last year, OPQ saved a more quantitative analysis of its efforts for the other yearly publication it put out, on …

    • FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)April 3rd, 2024

      Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress.  This year is no different, and in fact some of …

    • Congressional Hearing on LDTs: Split on FDA Regulation but Support for VALIDApril 1st, 2024

      On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chair Brett Guthrie (R-KY), in announcing …