CDRH director Jeff Shuren tells an American Enterprise Institute panel that new regulatory reforms from Congress will be needed for FDA and industry t...
FDA Webview editor Jim Dickinson analyzes Texas federal judge Matthew Kacsmaryks memorandum opinion and order banning chemical abortions nationwide an...
A Texas judges late Friday (3/7) decision staying FDAs approval of mifepristone (Mifeprex) sees many reactions that worry about FDAs approval gold sta...
Federal Register notice: FDA announces a 5/18 Vaccines and Related Biological Products Advisory Committee meeting to discuss a Pfizer BLA for Abrysvo ...
Federal Register notice: FDA announces a 6/9 Peripheral and Central Nervous System Drugs Advisory Committee to review an Eisai confirmatory study of A...
Federal Register notice: FDA announces a 5/12 Advisory Committee meeting to review a Sarepta Therapeutics BLA for a Duchenne muscular dystrophy drug.
FDA grants Reach Neuro a breakthrough designation for its Avantis platform, which the company says uses small electrical impulses delivered to the spi...
The Department of Justice officially appeals Texas federal judge Matthew J. Kacsmaryks 4/7 controversial court order to undo FDAs 2020 approval of mif...
