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More Suicide Deaths Linked to FDA Antidepressant Warnings

[ Price : $8.95]

University researchers worldwide urge FDA to reevaluate its use of a Boxed Warning in labeling for youth antidepressants after stu...

FDA Questions Data in Stealth NDA for Barth Syndrome

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FDA reviewers appear unconvinced that a Stealth BioTherapeutics NDA for elamipretide, a mitochondria-targeted therapy for treating...

Covid/Flu Rapid Test Authorized for OTC Use

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FDA grants a de novo marketing authorization for over-the-counter Healgen Rapid Check Covid-19/Flu A&B Antigen Test.

Workshop Advances Brain/Computer Interface Assessment

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FDA releases the transcript from a two-day workshop held in conjunction with NIH on developing clinical outcome assessments to dem...

Two Stakeholder Comments on BCG-Unresponsive Guide

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Two stakeholders recommend changes to an FDA draft guidance on treatment development for Bacillus Calmette-Guerin-Unresponsive Non...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

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...