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30 No-Longer-Marketed NDAs Withdrawn

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Federal Register notice: FDA withdraws approval of 30 NDAs from multiple applicants after they notified the agency that the produc...

FDA OKs OTC Hearing Aids

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FDA authorizes personal sound amplification products as over-the-counter hearing aids for some consumers.

Replacement Reagent Instrument Family Policy Guidance

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FDA publishes an updated guidance on replacement reagent and instrument family policy for in vitro diagnostic devices.

CGMP Violations at Verde Cosmetic Labs

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FDA warns Northridge, CA-based Verde Cosmetic Labs about CGMP violations in its production of finished drugs.

NIH Did Not Ensure Trial Reporting: OIG

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The HHS Office of Inspector General says the National Institutes of Health failed to enforce federal requirements that clinical tr...

Drug Inspections at Operational Levels: Throckmorton

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Attorney Douglas Farquhar says FDA speakers at a GMP conference indicated that domestic drug facility inspections are back at oper...

Emergent BioSolutions Warning Letter Out

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FDA warns Baltimore, MD-based Emergent BioSolutions about repeat CGMP violations in its manufacturing of finished drugs.

Case Safety Report Transmission Guide

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FDA publishes a regional implementation guide for an International Council on Harmonization document on electronic transmission of...

Roche sBLA for Polivy in Large B-Cell Lymphoma

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FDA accepts for review a Roche supplemental BLA for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus...

FDA Priority Review for Lynparza sNDA

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FDA accepts for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with abiraterone and predni...