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The Alliance to Save America’s 340B Program (ASAP) — a coalition of industry stakeholders, community health centers and provider and consumer advocates — has called for reforms of the drug discount program for hospitals that treat low-income patients.
The Biden administration has asked Congress for almost $200 million in additional FDA funding for fiscal 2024 to enhance medical product safety and an extra $105.3 million to fully fund increases in the agency’s employee pay.
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.