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FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Evig LLC and Won Industry Co.

Medical Devices

FDA Allows Emergency Use of Coronavirus Test

FDA issues a coronavirus emergency use authorization to permit the wider use of a Centers for Disease Control and Prevention 2019-nCoV Real-Time RT-PC...

Federal Register

Info Collection on Drug Making Emergency Plan

Federal Register notice: FDA submits to OMB an information collection extension for Planning for the Effects of High Absenteeism To Ensure Availabilit...

Federal Register

Info Collection on FDA Fellowships Apps

Federal Register notice: FDA sends to OMB an information collection revision entitled Application for Participation in FDA Fellowship and Traineeship ...

Federal Register

FDA Vaccines/Related Biologicals Panel Renewal

Federal Register notice: FDA renews for two years its Vaccines and Related Biological Products Advisory Committee charter.

Human Drugs

FDA Testing Results Posted on NDMA in Metformin

FDA posts laboratory results showing N- Nitrosodimethylamine levels in some metformin products.

Human Drugs

Priority Vouchers Do Little for Development: GAO

A new Government Accountability Office report on FDAs priority review voucher program finds that they have had little or no effect on drug development...

Human Drugs

FDA/FTC Curbing False Biological/Biosimilar Promos

FDA and FTC agree to crack down on anti-competitive practices, such as making false or misleading statements comparing biological reference products a...

Medical Devices

FDA Clears Qynapse Brain Analysis Software

FDA clears a Qynapse 510(k) for its QyScore software that analyzes brain MRI markers that occur early in diseases such as Alzheimers disease, Parkinso...

Medical Devices

Boston Scientific Safety Notice on Ablation System

Boston Scientific issues an urgent field safety notice about installing a firmware update for its Maestro 4000 Cardiac Ablation System to remedy an un...