Federal Register notice: CDRH announces its Radiation Sterilization Master File Pilot Program, a voluntary program for companies that terminally steri...
FDA publishes a draft guidance recommending the content and format for submitting OTC monograph order requests to the agency.
Federal Register notice: FDA plans a 6/8 public meeting entitled Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimil...
FDA publishes a draft guidance recommending the design and conduct of studies evaluating the adhesion performance of a transdermal or topical drug del...
The National Cancer Institute helps launch the Pragmatica-Lung Study as part of an effort with FDA to modernize clinical trials.
FDA warns Totowa, NJ-based Omega Packaging Corp. about CGMP violations in its production of drugs as a contract facility.
A JAMA Network Open study from the University of Missouri-Kansas City finds a relationship between Class 3 medical device supplements and device recal...
Vanda Pharmaceuticals asks FDA to revoke its approval of a Teva ANDA for a generic form of Vandas sleep drug Hetlioz and recall the product.
