FDA Related News

Leadership Changes Affect FDA Priorities: Mintz Post

Two Mintz attorneys examine what has happened to some of former FDA commissioner Marty Makarys initiatives following his resignation.

Animal Drugs

Petition Urges FDA to Restrict Antibiotic Use in Animals

A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals for the routine use of...

Human Drugs

Evaluate Generic Bicalutamide Manufacturers: Petition

A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient safety issue in gener...

Human Drugs

Agency Seeks Updated Generic Accutane Labels

FDA asks manufacturers of generic Accutane to update the drugs labeling.

Biologics

FDA Backs Accelerated Pathway for UniQure Huntington's Therapy

FDA tells UniQure that data from its ongoing Phase I/II study of AMT-130 could serve as the primary basis for a BLA seeking accelerated approval for t...

Human Drugs

FDA, African Medicines Agency Agreement on Regulatory Harmonization

FDA and the African Medicines Agency sign a Statement of Cooperation establishing a formal framework for collaboration between the U.S. regulator and ...

Biologics

FDA Accepts Outlook Therapeutics' Resubmitted BLA for Lytenava

FDA accepts for review a BLA resubmission from Outlook Therapeutics seeking approval of ONS-5010/Lytenava (bevacizumab-vikg) for treating neovascular ...

Human Drugs

CGMP Violations Found in Sante Manufacturing Records

FDA warns Canadas Sante Manufacturing about CGMP issues found in an agency review of requested records detailing the firms manufacturing of over-the-c...

FDA Fails at Providing Risk Management Advice: Post

North Dakota State University economist Raymond March faults the way in which FDA provides risk management guidance to regulated companies.

Human Drugs

Restrict Some Lung Cancer Drugs: Petition

A cancer center precision medicine expert calls on FDA to require labeling changes for some non-small cell lung cancer immune checkpoint inhibitors to...