FDA Related News

Medical Devices

Bardy Diagnostic 14-day P-wave Monitor Cleared

FDA clears a Bardy Diagnostics 510(k) for its 14-Day version of the Carnation Ambulatory Monitor, a P-wave heart monitor.

Biologics

Endo BLA for Treating Buttock Cellulite

Endo International files a BLA for collagenase clostridium histolyticum for treating cellulite in the buttocks.

Human Drugs

Woodcock Sees Addiction as Top Public Health Threat

CDER director Janet Woodcock says addiction currently is the most serious threat to public health.

Human Drugs

FDA OKs Boehringer Lung Disease Drug

FDA approves Boehringer Ingelheim Pharmaceuticals Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in certain adults with ...

Medical Devices

FDA Wants Weight Loss Device Feedback

FDA seeks comment on a discussion paper on how to determine and consider benefit and risk in weight-loss medical devices.

Human Drugs

Seizure Drug Efficacy Extrapolation Guidance

FDA issues a guidance on clinical development of drugs to treat partial onset seizures in pediatric patients over age two.

Medical Devices

2 Humanitarian Use Guidances

FDA publishes two guidances relating to humanitarian use device designations and humanitarian device exemptions.

Federal Register

Info Collection Extension for Patent Submissions

Federal Register notice: FDA submits to OMB an information collection extension for NDA patent submission and listing requirements.

Federal Register

Proposal to Add 5 Bulk Drugs for Compounding

Federal Register proposed rule: FDA proposes to add five additional bulk drug substances to its drug compounding list.

FDA Funding Functional Capacity Assessment Tool

FDA funds VeraSci research into a virtual reality functional capacity assessment tool.