We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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.