FDA Related News

Human Drugs

FDA Cites Sterile Compounding Lapses at Nubratori

FDA cites Nubratori Inc. for multiple manufacturing and contamination-control deficiencies following a December inspection of the companys Torrance, C...

Human Drugs

HHS OIG Outlines Safe Harbor for DTC Drug Sales

HHS Office of Inspector General issues new guidance clarifying when pharmaceutical manufacturers can sell prescription drugs directly to patients enro...

Human Drugs

CGMP Issues at Malaysias Fulijaya Manufacturing

FDA warns Malaysias Fulijaya Manufacturing about CGMP violations in its production of finished drugs.

Human Drugs

Using AI in Tumor Assessment

A Friends of Cancer Research white paper explores the emerging role of AI-enabled tumor assessment tools and the framework needed to use them in valid...

Human Drugs

Roche Reports Positive Phase 2 Data for Obesity Drug

Roche says its experimental dual GLP-1/GIP receptor agonist CT-388 delivered substantial and statistically significant weight loss in a Phase 2 study ...

FDA Enforcement Year in Review

A Ropes & Gray year-end review examines significant changes in FDA and Justice Department enforcement actions pertaining to regulated industries and s...

Human Drugs

FDA Lifts Clinical Hold on Intellias Phase 3 Trial

FDA lifts a clinical hold on Intellia Therapeutics MAGNITUDE-2 Phase 3 trial evaluating nexiguran ziclumeran for patients with hereditary transthyreti...

Medical Devices

Warning Letter Issued to Meridian Bioscience

FDA sends a Warning Letter to Meridian Bioscience over serious quality system violations involving blood lead testing devices manufactured by its subs...

Medical Devices

FDA Warns MAST Biosurgery Over Manufacturing Violations

FDA issues MAST Biosurgery a Warning Letter after an August inspection cited serious manufacturing quality and safety reporting violations related to ...

Human Drugs

Drug Companies Using AI to Speed Submissions

Reuters reports that several drug companies say they are using artificial intelligence tools to speed up some of the time-intensive work needed for cl...