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Guide on Postmarketing Study Noncompliance

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Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Studies and Clinical Trials: Determining Good...

Veklury Approved for Covid Plus Renal Impairment

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FDA approves a Gilead Sciences supplemental NDA for the use of Veklury (remdesivir) in Covid-19 patients with severe renal impairm...

Cell, Gene Manufacturing Changes, Comparability

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FDA publishes a draft guidance on managing manufacturing changes for human cellular and gene therapy products.

Opill Approved as 1st OTC Oral Contraceptive

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FDA approves a Laboratoire HRA Pharma (recently acquired by Perrigo) NDA to move its contraceptive Opill (norgestrel) tablet from ...

Dr. Reddys Rituxan Biosimilar BLA Accepted

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FDA accepts for review a Dr. Reddys Laboratories BLA for its proposed biosimilar rituximab (Genentechs Rituxan) candidate.

FDA Guide on Postmarketing Noncompliance Good Cause

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FDA publishes a draft guidance with information on how it determines good cause for noncompliance with prescription drug section 5...

Ex-Sales Rep Debarment Withdrawn

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Federal Register notice: FDA withdraws its 1/25 debarment of former Aegerion Pharmaceuticals sales representative Mark Moffett bec...

Panel to Discuss Womb Tech Devices

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Federal Register notice: FDA announces a 9/20 Pediatric Advisory Committee meeting to discuss artificial womb technology devices.

Oncology Drug Pilot on LDT Performance Criteria

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Oncology Center of Excellence associate director Harpreet Singh describes a new pilot program to outline performance criteria for ...

Zyto Illegally Marketing Galvanic Skin Device: FDA

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FDA issues a second Warning Letter to Zyto Technologies in Lindon, UT, about its illegal marketing of the Zyto galvanic skin respo...