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Rep. Questions Musk Device Trial OK Before Inspection

[ Price : $8.95]

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

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FDA issues a revised final and draft guidance on the handling and retention of BA and BE testing samples.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

Mesoblast Refiling BLA for Remestemcel-L

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Mesoblast says it will refile its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease ...

FDA Warns Against Topical OTC Analgesics

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FDA issues a warning to not use certain over-the-counter analgesic products that are marketed for topical use to relieve pain befo...

PARP Inhibitor Ovarian Cancer Indications Withdrawn

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Federal Register notice: FDA announces that it is withdrawing approval of the indications for treating adult patients with advance...