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Magstim 510(k) for Brain Stimulator Cleared

[ Price : $8.95]

FDA clears a Magstim 510(k) for the Horizon 3.0, a transcranial magnetic stimulation device designed for the clinical setting.

Info Collection Revision on Drug Reporting

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Federal Register notice: FDA sends to OMB an information collection revision for a guidance entitled Postmarketing Adverse Experie...

Animal Drug Approval Docs Available

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Federal Register notice: FDA amends the animal drug regulations to reflect recent application-related actions for new animal drug ...

7-Item 483 Issued to ACRX Specialty

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FDA issues a seven-item Form FDA-483 to ACRX Specialty (Las Vegas, NV) after finding GMP problems during an inspection in July.

Pfizer Seeking EUA for Promising Covid Antiviral

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Promising new data on its investigational Covid-19 oral antiviral agent Paxlovid PF prompts Pfizer to plan its early submission to...

ReWalk Robotics Breakthrough on Home Exo-suit

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FDA grants ReWalk Robotics a breakthrough device designation for its ReBoot, an exo-suit intended to assist ambulatory functions i...

Panel Votes Down Prader-Willi Syndrome Drug

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An FDA advisory committee votes 12 to 1 that a Levo Therapeutics NDA for carbetocin nasal spray and its use for treating Prader-Wi...

FDA Approves Dyanavel XR ADHD Tablets

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FDA approves a Tris Pharma NDA for Dyanavel XR (amphetamine), extended release once-daily tablets for treating attention-deficit h...

Pathogen Reduction in Blood Components Guide

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Federal Register notice: FDA makes available a final guidance entitled Manufacture of Blood Components Using a Pathogen Reduction ...

Orphan Designation for Menarini Leukemia Drug

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FDA grants orphan drug designation to an investigational Menarini drug to treat relapsed/refractory acute myeloid leukemia.