FDA Related News

Human Drugs

Elemental Impurities Guidance Published

FDA issues an ICH guidance on limiting elemental impurities in drug products.

Federal Register

Workshop on Generic Regulatory Science Initiatives

Federal Register notice: FDA announces a 5/4 public workshop entitled FY 2020 Generic Drug Regulatory Science Initiatives.

Federal Register

FDA Withdraws 16 No-Longer-Marketed ANDAs

Federal Register notice: FDA withdraws approval of 16 ANDAs from multiple applicants after they notified the agency that their drug products were no l...

Federal Register

Guide on Diabetes Drug Safety Evaluations

Federal Register notice: FDA makes available a draft guidance entitled Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glyc...

Human Drugs

Alternate Electronic Format Guidance

FDA publishes a draft guidance recommending ways to provide regulatory submissions

FDA Postpones Foreign Inspections Until May

FDA postpones foreign inspection of regulated products until May due to the coronavirus outbreak.

Federal Register

GI Drugs Advisory Committee Renewal

Federal Register notice: FDA announces the renewal of its Gastrointestinal Drugs Advisory Committee for an additional two years beyond the current cha...

Human Drugs

CGMP Violations at Guangzhou Tinci

FDA warns Chinas Guangzhou Tinci about CGMP violations in its production of finished pharmaceuticals.

Medical Devices

FDA Explains Covid-19 Test Guidance

A CDRH Webinar explains provisions of an immediately-in-effect guidance on coronavirus tests developed in certain certified laboratories.

Human Drugs

AnaBios, FDA Study Human Primary Cardiomyocytes

AnaBios and FDA sign a research collaboration agreement to study adult human primary cardiomyocytes as a reference for cellular properties and drug-in...