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Federal Register

Nonvoting Industry Reps for CDER Panels Sought

Federal Register notice: FDA seeks industry organizations interested in participating in the selection of nonvoting industry representatives to serve ...

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Human Drugs

FDA Guide on Postmarketing Noncompliance Good Cause

FDA publishes a draft guidance with information on how it determines good cause for noncompliance with prescription drug section 505(o)(3) postmarketi...

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Federal Register

Ex-Sales Rep Debarment Withdrawn

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

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Federal Register

Panel to Discuss Womb Tech Devices

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

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Oncology Drug Pilot on LDT Performance Criteria

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

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Medical Devices

Zyto Illegally Marketing Galvanic Skin Device: FDA

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

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Medical Devices

FDA Hernia Repair Surgical Mesh Info

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

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Medical Devices

Draeger Recalls Ventilator Over Battery Issues

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

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Biologics

Cell, Gene Manufacturing Changes, Comparability

FDA publishes a draft guidance on managing manufacturing changes for human cellular and gene therapy products.

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Human Drugs

Opill Approved as 1st OTC Oral Contraceptive

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