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FDA issues a new draft guidance on Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control that proposes to remove...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

Federal Register

Public Meeting on FDA/Health Canada ICH Activities

FDA announces a 4/3 public meeting entitled U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Counc...

Human Drugs

FDA OKs Ofev for Lung Disease Scarring

FDA approves Boehringer Ingelheim Pharmaceuticals Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing interstitial lung diseases ...

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 3/6/2020.

Federal Register

Draft Guide on Including Older Patients in Trials

Federal Register notice: FDA makes available a draft guidance entitled Inclusion of Older Adults in Cancer Clinical Trials.

Federal Register

Policy for Coronavirus Testing Labs

Federal Register notice: FDA makes available a final guidance entitled Policy for Diagnostics Testing in Laboratories Certified to Perform High Comple...

Federal Register

CDER Regulatory Project Management Site Tours

Federal Register notice: CDER announces its decision to continue Regulatory Project Management Site Tours and Regulatory Interaction Program.