FDA Related News

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...

FDA General

Commissioner Search Down to 3: BioCentury

BioCentury identifies the names of three potential FDA commissioner candidates sent to the White House.

FDA General

Former Officials Find New Roles After FDA

Former CDER associate director for genomics Felix Frueh joins NDA Partners as an expert consultant, and former FDA chief of staff Lauren Silvis joins ...

Medical Devices

medPhoton ImagingRing CT Scan Cleared

FDA clears a medPhoton 510(k) for the ceiling-mounted ImagingRing, an in-room cone-beam computed tomography imaging system.

Medical Devices

Arthrosurface Toe Fixation Cleared by FDA

FDA clears an Arthrosurface 510(k) for its BOSS Toe Fixation System for stabilizing the first metatarsal that presents with a distal bone void.