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Novavax Covid Vaccine Showed Myocarditis Safety Signal: FDA

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FDA says Novavaxs Covid-19 vaccines two-dose primary series demonstrated significant efficacy results in clinical trials, but it a...

Guide on Device Electromagnetic Compatibility Considerations

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FDA releases a final guidance entitled Electromagnetic Compatibility (EMC)of Medical Devices that offers the agencys current think...

Electrical Stimulation Device for Premature Ejaculation

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Federal Register notice: FDA classifies non-implanted electrical stimulation devices for management of premature ejaculation into ...

Troubled Lupin Hires Former FDA NJ District Director

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India-based Lupin Pharmaceuticals hires recently retired FDA New Jersey District director Diana Amador-Toro as the companys senior...

GAO Calls Out Unfinished FDA Inspection Recommendations

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The U.S. Government Accountability Office writes HHS about the need for FDA to make it a high priority to act on inspection-relate...

Senate Bipartisan Bill on Device Cybersecurity

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U.S. Senators Jacky Rosen (D-NV) and Todd Young (R-IN) introduce their bipartisan Strengthening Cybersecurity for Medical Devices ...

FDA Extends Review of Amylyxs ALS Drug

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FDA extends the review of an Amylyx Pharmaceuticals NDA for AMX0035 (sodium phenylbutyrate and taurursodiol), for treating amyotro...

New Apyx Renuvion J-Plasma Handpiece Available

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FDA says it has approved a new dermal handpiece for the Apyx Renuvion/J-Plasma.

CFP Acquisitions FDA-483

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FDA releases the FDA-483 with five observations from an inspection at Tulsa, OK-based CFP Acquisitions, a sterile drug producer.

OIG Doesnt Fault a Device Doctor-Distributor

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Three Goodwin Procter attorneys describe safeguards that keep a physician-owned distributor of a medical device from facing anti-k...