A Government Accountability Office report finds that FDAs Generic Drug User Fee Amendments of 2012 program had a $174 million carryover in fiscal year...
FDA sends Pfizer a complete response letter on its BLA for a proposed biosimilar referencing Amgens Epogen/Procrit (epoetin alfa), citing GMP issues f...
Federal Register notice: FDA announces an 8/2 Arthritis Advisory Committee meeting to discuss a Janssen Biotech BLA for Plivensia (sirukumab injection...
BioCentury reports that FDA commissioner Scott Gottlieb wants to make redacted complete response letters publicly available.
FDA Review has posted the Federal Register notices for the week ending 6/23/2017.
Federal Register notice: FDA seeks comments on a submission involving proposed recommendations for industry on developing continuous manufacturing for...
A Public Citizen analysis of a draft executive order on prescription pricing and innovation says it caters too much to the pharmaceutical industry.
FDA approves a CSL Behring BLA for Haegarda, the first C1 esterase inhibitor (human) for subcutaneous administration to prevent hereditary angioedema ...