FDA Related News

FDA General

AdvaMed Urges HHS Reversal of FDA Staff Cuts

Advamed president Scott Whitaker writes HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care.

2024 Device Recalls Up, Drug Recalls Down: Sedgwick

The Sedgwick full-year recall report for 2024 shows medical device recalls increasing and drug recalls decreasing.

Medical Devices

Becton Dickinson Recalls ChloraPrep Lot

Becton Dickinson recalls one lot of ChloraPrep clear 1 mL applicators due to fungal contamination concerns.

Human Drugs

Multiple Violations at Jagsonpal Pharmaceuticals

FDA warns Indias Jagsonpal Pharmaceuticals about CGMP deviations and other violations in its manufacturing of active pharmaceutical ingredients.

Human Drugs

CGMP Deviations at Tyche Industries

FDA warns Indias Tyche Industries about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Medical Devices

Publish Guidance on Robotic Mastectomy: Petition

Harmed Americans for Reform in Medical Device Safety asks FDA to repost two safety communications and to analyze and post its findings on two studies ...

Top Five 2024 FDA Data Quality Issues

A Med Device Online guest column lists and analyzes FDAs top five data quality citation issues in 2024.

Biologics

GSKs Penmenvy Vaccine for Meningococcal Disease

FDA approves a GSK BLA for Penmenvy (meningococcal Groups A, B, C, W, and Y vaccine) for preventing invasive meningococcal disease.

FDA General

Hundreds of FDA Employees Get Termination Letters

The Trump Administration fires hundreds of FDA probationary employees over the weekend as part of its efforts to trim government fat.

Human Drugs

Deciphera Pharma Gets OK for Romvimza

FDA approves a Deciphera Pharmaceuticals NDA for Romvimza (vimseltinib) for treating adult patients with symptomatic tenosynovial giant cell tumors.