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FDA publishes a draft guidance to help ANDA applicants prepare and submit pH adjuster waiver requests for specific types of drugs.[ Price : $8.95]
Federal Register notice: FDA announces a 6/9-10 Cellular, Tissue and Gene Therapies Advisory Committee meeting to discuss two blue...[ Price : $8.95]
Federal Register notice: FDA makes available two final device-specific guidance documents for the Safety and Performance Based Pat...[ Price : $8.95]
Federal Register notice: FDA permanently debars Lisett Raventos from providing services in any capacity related to an approved or ...[ Price : $8.95]
FDA publishes a final guidance on its approach to enforcement involving animal drugs compounded from bulk drug substances.[ Price : $8.95]
Pro golfer James Hahn is partnering with IBSA Pharma to promote its Licart prescription topical NSAID.[ Price : $8.95]
FDA grants Safer Technologies Program designation for a Pear Therapeutics pain control device.[ Price : $8.95]
Aeglea BioTherapeutics files a BLA for pegzilarginase for treating Arginase 1 Deficiency.