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Human Drugs

FDA Gives States Coronavirus Testing Authority

FDA updates a policy on diagnostic testing for coronavirus that allows states to take responsibility for tests developed and used by laboratories in t...

Federal Register

Dong Debarred Over Stimulants in Supplements

Federal Register: FDA debars Zhang Xiao Dong for five years from importing articles of food (including dietary supplements) or offering such articles ...

Federal Register

Jodoin Debarred Over Importing Controlled Drug

Federal Register notice: FDA debars Robert Richard Jodoin for five years from importing any drug into the U.S. after being convicted for importing a c...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Cipla Limited, Gojo Industries and Windlas Healthcare Private Limited.

Human Drugs

Novo Nordisk Halts 3 Hemophilia Trials Over Safety

Novo Nordisk stops two clinical trials in its concizumab Phase 3 development program and one clinical trial in the Phase 2 program due to safety issue...

Medical Devices

FDA Updates Coronavirus Test FAQs

FDA adds three questions to its FAQs on developing Covid-19 diagnostics.

Human Drugs

SGLT2 Inhibitor Safety Label Changes

FDA approves safety labeling changes for four SGLT2 inhibitors to recommend that their use be temporarily discontinued several days before planned sur...

Federal Register

Guide on Slowly Progressive, Low-Prevalence Rare Diseases

Federal Register notice: FDA makes available a final guidance on drugs for slowly progressive, low-prevalence rare diseases with substrate deposition.

Federal Register

Comments Extended on Homeopathic Drug Guide

Federal Register notice: FDA extends the comment period on a draft guidance entitled Drug Products Labeled as Homeopathic.

Federal Register

Competitive Generic Therapies Guidance

Federal Register notice: FDA makes available a final guidance entitled Competitive Generic Therapies.