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Guidance on Bioequivalence Testing Samples

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance entitled Handling and Retention of BA and BE Testing Samples.

CGMP Violations at Deqing Jiarou

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FDA warns Chinas Deqing Jiarou Daily Chemical Co. about CGMP violations in its production of finished drugs.

Multiple Violations in ReNovo Inspection

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FDA warns Bend, OR-based ReNovo that its reprocessed single-use medical devices are adulterated and misbranded and have Quality Sy...

Rep. Questions Musk Device Trial OK Before Inspection

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Rep. Earl Blumenauer asks FDA to explain why it approved human trials for Elon Musks Neuralink medical device before inspecting it...

Antibody Drug Conjugate Guidance Explained

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Two CDER Office of Clinical Pharmacology doctors use a podcast to explain a new guidance on considerations for antibody-drug conju...

High Court Skeptical on Mifepristone Restrictions

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The majority of U.S. Supreme Court justices appear skeptical during oral arguments on whether there should be a ban or any new res...

Leonowens Debarred for 5 Years

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Federal Register notice: FDA issues an order to debar Phillip Leonowens for a period of five years from importing or offering for ...

Clinical Data Interchange Standards Update

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Federal Register notice: FDA announces support for the Clinical Data Interchange Standards Consortium Standard for Exchange of Non...

Revised BA/BE Sample Handling Guidance

[ Price : $8.95]

FDA issues a revised final and draft guidance on the handling and retention of BA and BE testing samples.

Bioresearch Monitoring Issues at New York Site

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FDA warns Dr. Bret Rutherford about violations in his work as a clinical study investigator at the New York State Psychiatric Inst...