Apr 16, 2020
Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19
Apr 03, 2020
Coronavirus (COVID-19) Update: FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19
Jan 28, 2020
FDA Continues Strong Support of Innovation in Development of Gene Therapy Products
Nov 27, 2019
FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health
Aug 06, 2019
Statement by Peter Marks, M.D., Ph.D., director of FDA's Center for Biologics Evaluation and Research, on data accuracy issues with recently approved gene therapy
Jun 03, 2019
REGENXBIO Selects Skyland PIMS(TM) as their Process and Product Data Management Software System
May 14, 2019
FDA Grants Market Clearance for the OrSense NBM200; the First Noninvasive Hemoglobin System Cleared for Use in Blood Donation Centers
Apr 19, 2019
PDA Confirms Five Regulatory Speakers at 2019 Biosimilars and Vaccines Conference
Mar 26, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA's Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., on efforts to promote and foster blood pathogen reduction technologies
Nov 16, 2018
Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA's efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs
Oct 25, 2018
Dovel Technologies Awarded Biologics Surveillance IDIQ
Jul 12, 2018
Laboratory for Advanced Medicine Names Jinjie Hu as Chief Regulatory Officer
Jan 14, 2018
WuXi Biologics Appoints Dr. Chiang Syin, a Former FDA Officer as Chief Quality Officer
Dec 04, 2017
Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices
Nov 16, 2017
FDA announces comprehensive regenerative medicine policy framework
Sep 28, 2017
FDA improves access to reports of adverse drug reactions
Sep 06, 2017
Rebiotix Appoints Edward S. Burd, Ph.D., to Head of Regulatory Affairs