Support and caution is expressed by industry commenters on an FDA draft guidance on continuous manufacturing.
Two stakeholders submit comments and suggestions for an FDA draft guidance on bioavailability studies in NDAs or INDs.
Federal Register notice correction: FDA corrects the docket number on a 5/10 notice entitled Maximal Usage Trials for Topically Applied Active Ingredi...
Federal Register notice: FDA submits to OMB an information collection extension entitled Labeling of Nonprescription Human Drug Products Marketed With...
Heritage Pharmaceuticals recalls one lot of amikacin sulfate injection, USP, 1g/4 mL (250mg/mL) and one lot of prochlorperazine edisylate injection, U...
Stakeholders representing various interests tell FDA their positions on biosimilar and interchangeable insulins.
Two attorneys writing for Washington Legal Foundation say a new Justice Department guidance for its prosecutors reiterates the importance of corporate...
FDA issues two documents with information on its work involving regenerative medicine therapies.