Four drug industry stakeholders ask FDA to clarify elements in a draft guidance on interoperable exchange of information under the Drug Supply Chain S...
Pacira BioSciences plans to submit a supplemental NDA early next year to broaden the label on its post-surgical pain drug Exparel (bupivacaine extende...
CBER announces a 10/5 Webinar entitled Study Data Standards Update for CBER: Your Guide to a Successful Submission.
FDA lifts its clinical hold on Sareptas investigational Duchenne muscular dystrophy drug SRP-5051.
FDA warns St. Louis, MO-based Leaf of Life that its Web site takes orders for dietary supplements that are legally considered to be misbranded unappro...
FDA approves expanded labeling for Boston Scientifics Watchman FLX Left Atrial Appendage Closure Device to include a 45-day dual anti-platelet therapy...
CDER scientists are working to improve the bioavailability of generic drugs that do not dissolve well in water.
Federal Register notice: FDA issues a priority review voucher to Marinus Pharmaceuticals for gaining approval of a rare pediatric disease product appl...
