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Device Panel Votes Down Neovascs Reducer

[ Price : $8.95]

FDAs Circulatory System Devices Advisory Panel votes 13 to 3 against recommending PMA approval for Neovascs Reducer for treating c...

CGMP Violations at Indias Shilpa Medicare Limited

[ Price : $8.95]

FDA warns Indias Shilpa Medicare Limited about CGMP and field alert reporting violations in its manufacturing of finished drugs.

Guidance on ANDA References to Approved Drug Products

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FDA issues a guidance on how ANDA applicants should accurately refer to a reference-listed drug, reference standard, and the basis...

FDA Delaying AED Accessory Premarket Approval

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FDA says it is delaying until 2/3/2022 enforcement of compliance with PMA requirements for AED accessories.

NIH Ends Lilly Covid Antibody Study

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NIH ends enrollment in a clinical trial of a Lilly investigational monoclonal antibody intended to treat hospitalized Covid-19 pat...

Homeopathic Drug Marketer Can Challenge FDA Policy: Court

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The Washington, DC District Court rules that a recent FDA decision to remove a decades-old compliance policy affecting unapproved ...

CGMP Violations at KVK-Tech

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FDA warns KVK-Tech about CGMP violations in its production of finished drugs.

Meeting on Drug Supply Chain Security Act

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Federal Register notice: FDA announces a 12/8-9 virtual public meeting entitled The Drug Supply Chain Security Act Pilot Project P...

Panel Reviews Spironolactone for Certain Heart Failure Patients

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Federal Register notice: FDA announces a 12/16 advisory committee meeting to discuss spironolactone for the proposed treatment of ...

Panel to Discuss Novartis sNDA for Entresto

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Federal Register notice: FDA announces a 12/15 advisory committee meeting that will review a Novartis supplemental NDA for Entrest...