FDA Related News

Balance AI Optimism and Pessimism: Califf

FDA commissioner Robert Califf says he sees value in artificial intelligence and agrees that its important to also look at the risk of harm that can b...

Human Drugs

Roche/Genentech Suggestions for nAMD Guidance

Roche/Genentech make suggestions for clarification and improvement to an FDA draft guidance on developing treatments for neovascular age-related macul...

Medical Devices

Patient Access to At-Home Technologies

CDRH asks for public comment on eight questions about using medical technologies in a home setting.

Human Drugs

Doc Bought Oncology Meds to Sell for Profit: DoJ

A New Jersey oncologist becomes the third doctor to plead guilty to participating in a scheme to purchase prescription oncology drugs under false pret...

Medical Devices

FDA Clears Ezra Flash AI for MRI Quality

FDA clears an Ezra 510(k) for its artificial intelligence-enabled Ezra Flash and its use in enhancing MR image quality.

FDA General

CDER Drug Policy Guru Heads to Morgan Lewis

CDER Office of New Drug Policy director Maarika Kimbrell leaves the agency to re-enter private legal practice at Morgan Lewis as a partner resident.

Human Drugs

Clinical Hold on PepGen IND Application

FDA places a clinical hold on a PepGen IND application for a Phase 1 trial of PGN-EDODM1 to treat myotonic dystrophy Type 1.

Human Drugs

Precision BioSciences to Meet with FDA on Azer-Cel

Precision BioScience says it will meet with FDA in June to discuss a regulatory way forward through a Phase 2 trial for its azer-cel in patients with ...

Medical Devices

Groups Want Regulation of Lab-Developed Tests

Sixteen advocacy organizations urge FDA to regulate laboratory-developed tests if Congress fails to produce a strong bill.

Biologics

Junshi Bio Inspection to Advance Toripalimab BLA

FDA completes a previously delayed pre-licensing inspection of China-based Shanghai Junshi Biosciences breakthrough cancer drug toripalimab manufactur...