FDA Related News

Medical Devices

Home AFib Blood Pressure Monitor De Novo Granted

FDA grants a de novo marketing authorization to Omron Healthcare for its new home blood pressure monitors featuring AI-powered atrial fibrillation det...

Medical Device Recalls Up, Drugs Down: Sedgwick

The Sedgwick third quarter 2024 recall index documents an increase in medical device recalls and a decrease in drug recalls.

Medical Devices

SonoMotion De Novo for Stone Clear Ultrasound

FDA grants SonoMotion a de novo marketing authorization for its Stone Clear device for the ultrasound treatment of post-lithotripsy kidney stone fragm...

Marketing

False or Misleading Xeomin Promotion: FDA

FDA cautions Merz over misleading representations about its Xeomin in a promotional piece featuring celebrity spokesman Nate Berkus.

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FDA publishes a draft guidance on the nonclinical safety assessment of oligonucleotide-based therapeutics.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

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%.