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The FDA has decided the postpandemic fate of 72 final guidances published over the past three years to address COVID-19 issues, choosing to withdraw about one-third, phase out another one-third and retain most of the remainder but plan to update them in the near future.
In a potentially “game-changing” legislative move, the Food and Drug Omnibus Reform Act of 2022 (FDORA) has given the FDA the option to rely on review of records and other information collected from a manufacturer in lieu of some types of on-site inspections.
The FDA’s Oncologic Drugs Advisory Committee cleared the way for a new combination treatment aimed at providing curative therapy for patients with previously untreated large B cell lymphoma.
The Biden administration has asked Congress for $7.2 billion in funding for the FDA for fiscal 2024 — an approximately 10 percent increase over what the agency received in fiscal 2023.