FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

Rituxan Approved for Granulomatosis in Children

FDA approves Genentechs Rituxan (rituximab) injection to treat granulomatosis with polyangiitis and microscopic polyangiitis in children two years of ...

Marketing

Galt Marketing Email Gets FDA Warning

An email distribution by Galt Pharmaceuticals to health professionals draws an FDA Warning Letter on insomnia drug Doral (quazepam) tablets because it...

Human Drugs

Meeting on ICH Clinical Trial Guide

Federal Register notice: FDA announces a 10/31 public meeting on an International Council on Harmonization guideline on clinical trial considerations.

Medical Devices

Digital Health Innovation Guidances Out

FDA issues new and updated guidances to clarify regulatory oversight of various digital health tools.

Human Drugs

Zogenix Resubmits Dravet Syndrome NDA

Zogenix resubmits an NDA for Fintepla (fenfluramine hydrochloride) for treating seizures associated with Dravet syndrome.

Federal Register

Draft Guide on Device e-Submissions

Federal Register notice: FDA makes available a draft guidance on medical device regulatory electronic submissions.

Human Drugs

CDER Reorganization Clears Congress

CDER director Janet Woodcock says Congress has approved the Centers reorganization plan and it is being implemented.

Human Drugs

Advisors Asked About Pediatric Singulair Neuropsych Events

FDA asks members of two advisory committees for input on labeling options and communications strategies to address neuropsychiatric side events of Mer...

Human Drugs

Janssen sBLA for Combination Darzalex Use in Myeloma

FDA approves a Janssen Biotech supplemental BLA for use of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for tr...

Human Drugs

Apotex Recalls Some OTC Ranitidine Tablets

FDA announces an Apotex recall of two strengths of generic Zantac labeled for Walgreens, Walmart, and Rite-Aid due to possible NDMA contamination.