FDA Related News

Human Drugs

Medication Errors Related to IND Labels Discussed

FDA and the Reagan-Udall Foundation hold a two-day meeting on the role of investigational drug labels in medication errors.

Human Drugs

Guide on Trial Data Sets for NASH Drugs

FDA releases a guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohep...

Human Drugs

Coordinated National Trial Infrastructure Needed: Gottlieb

Former FDA commissioner Scott Gottlieb says the nation needs a coordinated national clinical trial infrastructure for use during public health emergen...

Use Risk Assessments on Trial Monitoring Decisions: FDA

FDA revises its guidance on remote monitoring of clinical trials conducted during the Covid emergency and whether onsite monitoring should audit the r...

Human Drugs

2 New MAPPs Out

CDER issues Manuals of Policies and Procedures on scientific interest groups and data standards.

Medical Devices

MiRus Lumbar Interbody Device Cleared

FDA clears a MiRus 510(k) for its IO Expandable Lumbar Interbody device for use in posterior and transforaminal fusion procedures.

Human Drugs

UCB Gets Expanded Pediatric Indication for Briviact

FDA approves a UCB expanded indication for Briviact (brivaracetam) tablets, oral solution, and injection to treat partial-onset seizures in patients a...

Human Drugs

Anixa Gains IND Approval of CAR-T for Ovarian Cancer

FDA approves an Anixa Biosciences IND for its CAR-T (Chimeric Antigen Receptor-T cell) therapy and its use in treating ovarian cancer.

Guide Revised on Trials Conducted During Covid

FDA revises its guidance entitled Conduct of Clinical Trials of Medical Products During the Covid-19 Public Health Emergency.

Medical Devices

De Novo Granted for Smart Knee Replacement

FDA grants a de novo authorization to Zimmer Biomet and Canary Medical for their tibial extension for Persona IQ, the first smart knee for total knee ...