Mallinckrodt agrees to pay $100 million to settle Federal Trade Commission charges that it violated antitrust laws when its subsidiary Questcor acquir...
Federal Register Notice: FDA makes available a draft guidance for industry entitled Considerations in Demonstrating Interchangeability With a Referenc...
Federal Register Notice: FDA makes available a guidance entitled Assessment of Abuse Potential of Drugs.
Federal Register Notice: FDA determines that Endo Pharmaceuticals Parkinsons drug Symmetrel (amantadine hydrochloride), syrup, 50 milligrams/5 millili...
Former Rep. Henry Waxman says some orphan drug financial incentives may no longer be needed because some companies are gaming the system to use them t...
FDA commissioner Robert Califf says advisory committees are of questionable value in their current form and the agency is evaluating needed changes to...
FDA denies as premature a Lilly request that it revise the definition of biological product to include Forteo and not approve any ANDA referencing For...
FDA provides a legal memorandum on its approach to manufacturer communication about unapproved uses of drugs and medical devices within the context of...