FDA Related News

Human Drugs

Nearly 1,000 Generic Drugs OKd in 2023

The CDER Office of Generic Drugs 2023 annual report details the 956 ANDAs approved or tentatively approved last year.

Election Year Will Affect FDA Actions: Attorneys

Two Hogan Lovells attorneys and two Greenleaf Health executives discuss FDA actions in this election year at a recent J.P. Morgan healthcare conferenc...

Medical Devices

Breakthrough Status for Cognitive Behavioral Therapy

FDA grants Better Therapeutics a breakthrough device designation for its Cognitive Behavioral Therapy platform that is intended to treat adults with m...

Federal Register

Guide on Drug/Biologic Covid Studies

Federal Register notice: FDA makes available a final guidance entitled Assessing Covid19-Related Symptoms in Outpatient Adult and Adolescent Subjects ...

Federal Register

McLaren Debarred by FDA for 5 Years

Federal Register notice: FDA debars Taylor McLaren for five years from importing or offering for import any drug into the U.S.

Human Drugs

BLA Accepted for Treating Lung Cancer

FDA accepts for review a Daiichi Sankyo and AstraZeneca BLA for datopotamab deruxtecan (Dato-DXd) for treating certain adult patients with locally adv...

Federal Register

Guide on Device Small Business Qualification

Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Medical Device User Fee Small Business Qualification and...

Human Drugs

Covid Symptoms in Clinical Trials Final Guidance

FDA publishes a new final guidance on assessing Covid-19-related symptoms in adults and adolescents who are subjects in clinical trials of drugs to tr...

Medical Devices

FDA Real-World Evidence Guide Stirs Critics

Five stakeholders make suggestions for changes to an FDA draft guidance on using real-world evidence in medical device regulatory decision-making.

Medical Devices

More Companies Should Join TAP: Shuren

CDRH director Jeffrey Shuren urges more medical device companies to join the Total Product Lifestyle Advisory Program.