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.
Federal Register notice: FDA announces a 5/18-19 public meeting entitled Potential Medication Error Risks with Investigational Drug Container Labels....
The CDER Office of New Drugs 2020 Annual Report describes lessons learned from Covid-19 and challenges OND will face in 2021 as the pandemic winds dow...