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Two Stakeholder Comments on BCG-Unresponsive Guide

[ Price : $8.95]

Two stakeholders recommend changes to an FDA draft guidance on treatment development for Bacillus Calmette-Guerin-Unresponsive Non...

Significant CGMP Violations at MMC Healthcare

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FDA warns Indias MMC Healthcare about CGMP violations in its production of finished drugs.

Objectionable Conditions at LSU Institutional Review Board

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FDA warns the Louisiana State University institutional review board that it failed to follow legislation and regulations to protec...

FDA Releases Apitoria Pharma FDA-483

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FDA releases the form FDA-483 with 10 observations from an inspection at the Apitoria Pharma active pharmaceutical ingredient manu...

8 Observations in Biocon FDA-483

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FDA releases the form FDA-483 issued following an inspection at the Biocon sterile drug product manufacturing facility in Johor, M...

House Wants FDA Briefing on Fake Ozempic

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The House Energy and Commerce Committee asks FDA for a staff briefing about the presence of counterfeit copies of Novo Nordisks Oz...

Clinical Hold Slapped on Kezar Lupus Trial

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FDA orders a clinical hold on Kezar Life Sciences IND for zetomipzomib and its investigational use in treating lupus nephritis.

Sublocade Priority Review for Expanded Labeling

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FDA awards a priority review for an Indivior prior approval supplement for Sublocade (buprenorphine) extended-release injection fo...

AdvaMed Seeks FDA Best Practice on Trial Diversity

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AdvaMed says that as FDA begins receiving and reviewing diversity action plans, it should publicly disclose any key best practices...

Comments Sought on Pharmaceutical Quality Terminology

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FDA requests comments on a draft document about controlled terminology/vocabulary that applies to a set of coded quality attribute...