FDA Related News

Federal Register

Info Collection Extension for GCP Guide

Federal Register notice: FDA seeks comments on an information collection extension for Guidance for Industry on E6 (R2) Good Clinical Practice; Intern...

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.

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.

Human Drugs

Mallinckrodt Paying $15 Million in False Claims Act Case

The Justice Department says Mallinckrodt is paying $15.4 million to resolve allegations that it paid illegal kickbacks to doctors to induce Medicare A...