Former FDA commissioner Robert Califf says the best long-term way to control drug prices is through value-based pricing.
FDA selects Pew Charitable Trusts drug regulatory policy expert Elizabeth Jungman as Office of Regulatory Policy director.
FDA issues a guidance to help sponsors determine information and testing to submit for orthopedic devices containing ultrahigh molecular weight polyet...
FDA says using the Stryker Wingspan stent system on patients not meeting criteria in the approved indications for use increases the risk of stroke or ...
FDA approves a Boston Scientific PMA for the LOTUS Edge Aortic Valve System.
The NIH works with FDA to modify government oversight of gene therapy.
FDA publishes a guidance on the content and f.ormat of non-clinical bench performance testing information in premarket submissions.
FDA releases a final guidance on Unique Device Identification: Convenience Kits.