The CDER Offices of Generic Drugs and Pharmaceutical Quality issue a report on the FY 2020 GDUFA Science and Research Program activities.
Medical device consultant Adam Atherton offers three recommendations for preparing for an FDA quality system audit.
FDA provides information for Covid-19 test developers and organizations establishing a Covid testing program.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for TransMedics OCS Lung System.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for DT MedTechs Hintermann Series H3 Total Ankle Re...
Federal Register notice: FDA reopens the comment period on a 12/9/2020 notice entitled Best Practices in Developing Proprietary Names for Human Nonpre...
FDA warns Chinas Foshan Biours Biosciences about CGMP violations in its production of OTC drugs.
FDA warns Mexicos Dibar Nutricional about CGMP violations in its manufacturing of OTC drugs.