FDA lists enhancements to the CDRH electronic medical device reporting system and sets a schedule for future changes.
Federal Register notice: FDA corrects the docket number associated with a 6/30 notice on a draft guidance entitled Patient-Focused Drug Development: S...
UK researchers say genetic evidence supports two-thirds of drugs FDA approved in 2021.
FDA Webview posts the Federal Register notices that published during the week of our annual Fourth of July (Independence Day) holiday break.
U.S. Rep. Abigail Spanberger (D-VA) introduces the Banning Misleading Drug Ads Act that is intended to prevent manufacturers from obscuring dangerous ...
HRA Pharma files an NDA for an Rx-to-OTC switch for the companys Opill (norgestrel .075 mg), a progestin-only daily birth control pill.
After a 22-year career at FDA, CDER Office of Generic Drugs Division of Legal and Regulatory Support deputy director Martin H. Shimer II joins Lachman...
The National Hemophilia Foundation says FDA should require a REMS for two investigational gene therapies being reviewed as hemophilia treatments with ...