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Woodcock Elevated to Commissioners Office as Advisor

[ Price : $8.95]

Former CDER director Janet Woodcock, who has been on detail at the White Houses Operation Warp Speed, moves to the Office of Commi...

Notice on OTC Drug Monograph Fees Withdrawn

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Federal Register notice: FDA withdraws a 12/29 Federal Register notice entitled Fee Rates Under the Over-the-Counter Monograph Use...

FDA Defers Action on Avastin Biosimilar

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Citing Covid-19 concerns, FDA delays action on Mylan/Biocons BLA for an Avastin biosimilar.

510(k) Clearance for CardioWise Heart Analysis Software

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FDA clears CardioWises Stretch Quantifier for Endocardial Engraved Zones image analysis software.

Info Collection on Condom Labeling

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Federal Register notice: FDA seeks comments on an information collection extension for guidance on latex condom labeling.

Gene Therapy for Neurodegenerative Diseases Guidance

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FDA issues a draft guidance on the development of human gene therapy for neurodegenerative diseases.

FDA Lifts Marker Therapeutics Phase 2 Trial Partial Hold

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FDA lifts a partial clinical hold on a Marker Therapeutics Phase 2 trial of an investigational drug to treat post-transplant acute...

FDA Warns Reddy Naturals for Selling Unapproved Drugs

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FDA warns Reddy Naturals that it is marketing unapproved and misbranded new drugs.

Q-Submission Guidance

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FDA issues a guidance with the latest provisions of the Q-Submission program for medical devices agreed to under MDUFA 4.

Medical Device Safer Technologies Program Guidance

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FDA issues a guidance with an overview of the new Safer Technologies Program for some medical devices and device-led combination p...