Federal Register notice: FDA seeks comments on an information collection extension for Annual Reporting for Custom Device Exemption OMB Control Number...
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.
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 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.