FDA Related News

Biologics

Adaptimmune Therapeutics Plan Lete-Cel BLA

Adaptimmune Therapeutics plans a rolling BLA submission for cell therapy lete-cel in certain people with synovial sarcoma or myxoid/round cell liposar...

Human Drugs

7 Observations on U.S. Specialty FDA-483

FDA releases the form FDA-483 with seven observations from an inspection at the U.S. Specialty Formulations outsourcing facility in Allentown, PA.

Human Drugs

Oligonucleotide-Based Therapeutic Assessment

FDA publishes a draft guidance on the nonclinical safety assessment of oligonucleotide-based therapeutics.

Medical Devices

NovaBone Putty Cleared for Intervertebral Disc Repair

FDA clears a NovaBone Products 510(k) for its NovaBone Putty and its expanded use in the intervertebral disc space.

SCOTUS Decisions Effect on FDA Analyzed

Six Squire Patton Boggs attorneys lay out the impact of four recent Supreme Court decisions on several aspects of FDA regulation.

Human Drugs

Boston Scientific Recalls Cryoablation Catheters

Boston Scientific recalls (Class 1) its POLARx and POLARx FIT Cryoablation Balloon Catheters because of atrio-esophageal fistula risks.

Medical Devices

LivaNova Sleep Apnea Device Meets Endpoints

LivaNova says its aura6000 obstructive sleep apnea treatment met the safety and efficacy endpoints in the OSPREY trial in adults.

FDA Needs Inspection Staff Recruitment Plan: GAO

GAO healthcare director Mary Denigan-Macauley says FDA needs a plan and a strategy for recruiting and retaining new facility inspectors.

Medical Devices

FDA Clears GEs Head-Only MRI Device

FDA clears a GE HealthCare 510(k) for its Signa Magnus, a 3.0T high-performance, head-only MRI scanner.

Human Drugs

Require Studies for Prednisolone Eye Drops: DifGen

DifGen asks FDA to require long-term refrigerated stability studies for any generic form of its Prednisolone Ophthalmic Solution 1%.