FDA solicits comment on a plan to modify packaging of some immediate release opioids in fixed-quantity, unit-of-use blister packs.
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.
Attorney Ethan Townsend says a recent Supreme Court decision will change the landscape and introduce new uncertainty into companies use of the impossi...