Federal Register notice: FDA announces a 9/13 public workshop on Developing a Framework for Regulatory Use of Real-World Evidence.
Federal Register notice: FDA announces an 11/28 public workshop entitled Cardiac Troponin Assays to discuss developing the innovative assays which are...
FDA safety reviewers raise some concern with a Janssen Biotech BLA for Plivensia (sirukumab) injection going before the agencys Arthritis Advisory Com...
FDAs Vaccines and Related Biological Products Advisory Committee votes 12 to 1 to recommend approval of a Dynavax Technologies BLA for Heplisav-B [hep...
A White House-commissioned report urges President Trump to declare a national emergency in order to deal with the ongoing opioid crisis.
ICU Medical recalls one lot of 0.9% sodium chloride injection, USP 1,000 mL due to a confirmed customer complaint of particulate matter identified as ...
FDA Review posts the Federal Register notices for the week ending 7/28/2017.
Apace Packaging recalls one lot of cyclobenzaprine HCl tablets, USP 5 mg 50ct unit dose, and one lot of amantadine HCl capsules, USP 100 mg 50ct unit ...