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Two stakeholders recommend changes to an FDA draft guidance on treatment development for Bacillus Calmette-Guerin-Unresponsive Non...[ Price : $8.95]
FDA warns Indias MMC Healthcare about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA warns the Louisiana State University institutional review board that it failed to follow legislation and regulations to protec...[ Price : $8.95]
FDA releases the form FDA-483 with 10 observations from an inspection at the Apitoria Pharma active pharmaceutical ingredient manu...[ Price : $8.95]
FDA releases the form FDA-483 issued following an inspection at the Biocon sterile drug product manufacturing facility in Johor, M...[ Price : $8.95]
The House Energy and Commerce Committee asks FDA for a staff briefing about the presence of counterfeit copies of Novo Nordisks Oz...[ Price : $8.95]
FDA orders a clinical hold on Kezar Life Sciences IND for zetomipzomib and its investigational use in treating lupus nephritis.[ Price : $8.95]
FDA awards a priority review for an Indivior prior approval supplement for Sublocade (buprenorphine) extended-release injection fo...