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FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Guangzhou Tinci Materials Technology and James R. Corbett.

Federal Register

Info Collection on Safety Communication Survey

Federal Register notice: FDA seeks comments on an information collection extension for FDA Safety Communication Readership Survey.

Human Drugs

Hahn says 1.1 Million Coronavirus Tests Shipped

FDA commissioner Stephen Hahn says that 1.1 million more coronavirus tests have just been shipped by nonpublic health labs.

Medical Devices

Guide on Electrosurgical Device 510(k)s

FDA issues a final guidance on 510(k) submissions for electrosurgical devices.

FDA General

Warning Letters Sent Over Unapproved Virus Products

FDA and FTC have issue seven Warning Letters to companies for allegedly selling fraudulent coronavirus products.

Federal Register

Topical Drug Product Contact Dermatitis Guide

Federal Register notice: FDA makes available a draft guidance entitled Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human ...

Human Drugs

FDA Cosmetic Talc Testing Report

FDA posts a final report from an agency-contracted sampling of talc-containing cosmetic products for the presence of asbestos.

Federal Register

Comments on Drug Safety Surveillance Best Practices

Federal Register notice: FDA reopens until 5/5 the comment period for a 11/7/2019 notice on Best Practices in Drug and Biological Product Postmarket S...

Human Drugs

FDA Eliminates CV Outcomes Data on Diabetes Drugs

FDA issues a new draft guidance on Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control that proposes to remove...

Human Drugs

Mylan/Biocon BLA for Avastin Biosimilar

FDA accepts for review a Mylan/Biocon BLA for MYL-1402O, a biosimilar candidate referencing Genentechs Avastin (bevacizumab).