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Veklury Approved for Covid Plus Renal Impairment

[ Price : $8.95]

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

FDA Guide on Postmarketing Noncompliance Good Cause

[ Price : $8.95]

FDA publishes a draft guidance with information on how it determines good cause for noncompliance with prescription drug section 5...

Ex-Sales Rep Debarment Withdrawn

[ Price : $8.95]

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

Panel to Discuss Womb Tech Devices

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Hernia Repair Surgical Mesh Info

[ Price : $8.95]

FDA publishes an online page describing hernias and their repair, with attention to using surgical mesh in the repair.

Draeger Recalls Ventilator Over Battery Issues

[ Price : $8.95]

Draeger Medical recalls its Oxylog 3000 Plus Emergency and Transport Ventilator after receiving reports that the device stopped ve...

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FDA publishes a draft guidance on managing manufacturing changes for human cellular and gene therapy products.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

[ Price : $8.95]

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