The Alliance for Cell Therapy Now calls on FDA and other agencies to act to measure outcomes related to regenerative cell therapies.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Rempex Pharmaceuticals Vabomere (vaborbactam an...
Federal Register notice: FDA sends to OMB an information collection extension for Reporting Associated With Designated New Animal Drugs for Minor Use ...
FDA warns Teligent Pharma about CGMP and Field Alert Report violations in its manufacturing of finished pharmaceuticals.
FDA warns OHM Pharma about CGMP and other violations in its manufacturing of finished pharmaceuticals.
FDA clears an OrthoGrid Systems 510(k) for its application PhantomMSK Trauma for use in orthopedic surgery.
New Government Accountability Office findings on FDAs foreign inspection program acknowledge improvements pointing up persistent remaining challenges,...
FDA releases its latest batch of Warning Letters that includes OHM Pharma and Teligent Pharma.