FDA revises an internal policy on Communicating Drug Approval Information that demands quicker online posting, from three days to two days, for the ap...
FDA has cleared a CSA Medical 510(k) to expand the use of its truFreeze catheter offerings to include a third spray kit called RapidAV Spray Kit.
FDA Review posts the Federal Register notices for the week ending 7/14/2017.
FDA commissioner Scott Gottlieb touts agency efforts to reduce the countrys opioid epidemic.
Federal Register notice: FDA announces the availability of additional draft and revised draft product-specific guidances that provide product-specific...
Mallinckrodt files a citizen petition asking FDA to assure that follow-on drug products citing its Inomax (nitric oxide) 800 ppm for inhalation as the...
FDAs Oncologic Drugs Advisory Committee votes to support approval of an Amgen BLA for a biosimilar version of Roches Avastin (bevacizumab) and a Mylan...
FDA approves a Janssen Biotech BLA for Tremfya (guselkumab) for treating adults with moderate to severe plaque psoriasis who are candidates for system...