FDA determines for patent extension purposes the regulatory review period for Intercept Pharmaceuticals Ocaliva (obeticholic acid).
FDA warns MiBo Medical Group about Quality System violations in its manufacturing of the MiBo Thermoflo.
FDA warns Koreas Barox about CGMP violations in its production of finished drugs.
FDA says its recognition of the ClinGen genetic data database will help speed development of novel diagnostic technologies to diagnose diseases and gu...
FDA says its researchers are evaluating a way to use mass spectrometry in drug quality control.
Federal Register notice: FDA makes available a draft guidance entitled Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs...
Federal Register notice: FDA makes available a final guidance entitled Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GD...
The U.S. Justice Department announces that medical device manufacturer ev3 has agreed to plead guilty to introducing an adulterated medical device int...