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The FDA outlined its current thinking for drug sponsors on assessing gastric pH-dependent drug-drug interactions (DDI) in a final guidance released Monday.
The FDA needs to set performance goals and metrics for its advanced drug manufacturing initiative to strengthen the U.S. supply chain, the Government Accountability Office (GAO) said in a report released Friday.
Sen. Bernie Sanders (I-Vt.) and Rep. Cori Bush (D-Mo.) have proposed legislation that would cap the list price of insulin at no more than $20 per vial.
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.
Responding to FDA Commissioner Robert Califf’s recent remarks regarding the value of advisory committee (AdComm) votes, two major industry advocates offered slightly different takes on the question.