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Federal Register notice: FDA reopens the comment period for its draft guidance entitled E6(R3) Good Clinical Practice: Annex 2.[ Price : $8.95]
FDA accepts for priority review an NS Pharma BLA for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy c...[ Price : $8.95]
FDA warns Elanco Animal Health that promotional materials for its Zenrelia are misbranded due to false and misleading representati...[ Price : $8.95]
An FDA safety alert says several manufacturers have recalled several lots of immune globulin intravenous and subcutaneous products...[ Price : $8.95]
Merck says it will seek FDA approval for new HIV regimen following its announcement of positive results from two pivotal Phase 3 t...[ Price : $8.95]
FDA clears a Beckman Coulter Diagnostics 510(k) for its DxC 500i Clinical Analyzer.[ Price : $8.95]
FDA warns Indias Shree Jaya Laboratories about CGMP deviations in its production of active pharmaceutical ingredients at a facilit...[ Price : $8.95]
FDA warns Chinas Linghai ZhanWang Biotechnology Co. about CGMP violations in its manufacturing of over-the-counter drugs.