Stakeholders generally praise a revised ICH guideline on clinical studies and suggest changes.
FDA releases its latest batch of Warning Letters that includes Herbal Healer Academy and NuCare Pharmaceuticals.
FDA approves a Clinuvel NDA for Scenesse (afamelanotide) for increasing pain-free light exposure in adult patients with a history of phototoxic reacti...
California becomes the first state in the nation to approve a bill to combat so-called pay-for-delay agreements between innovator and generic drug com...
FDA warns NuCare about many instances in which its listing information does not comply with applicable requirements.
A Philadelphia jury delivers an $8 billion punitive verdict against Johnson & Johnson and its alleged improper marketing of the antispychotic drug Ris...
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for NADAs and ANADAs during April, May, and Jun...
Medtronic submits a PMA supplement for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.