FDA Related News

Medical Devices

FDA Early Alert on Watchman Devices

FDA issues an alert after Boston Scientific notified customers that all lots of certain Watchman Access Systems have updated use instructions to preve...

Medical Devices

Quarantine Some Medline ReNewal Catheters

An FDA Early Alert says Medline ReNewal recommends that some reprocessed St. Jude electrophysiology catheters be quarantined due to the possibility th...

Human Drugs

FDA Accelerated Approval for Jazz Modeyso

FDA grants accelerated approval for Jazz Modeyso to treat diffuse midline glioma.

FDA Publishes Data Standards Program Update

FDA publishes the FY 2025 Quarter 2 update to the CBER/CDER Data Standards Program Action Plan.

Human Drugs

Clarametyx Gets Fast Track for Pulmonary Infection Drug

FDA grants Clarametyx Biosciences both fast track and qualified infectious disease product designations for its lead therapeutic candidate, CMTX-101, ...

Medical Devices

Mectronic Medicale Multiple Violations

FDA warns Italys Mectronic Medicale about Quality System, Medical Device Reporting, and other violations in its illegal manufacturing and marketing of...

Human Drugs

Two-Day Workshop on Oncology Patient Registries

FDAs Oncology Center of Excellence announces a two-day virtual public workshop to advance the development of patient registries in oncology, with a fo...

Human Drugs

CGMP Violations at Oasis Medical

FDA warns Glendora, CA-based Oasis Medical about CGMP violations in its production of finished drugs.

FDA General

Laura Loomer Targets Makary Over Prasad Exit

Right-wing commentator Laura Loomer publicly criticizes FDA commissioner Marty Makary over recent comments surrounding the departure and mooted return...

FDA General

Former FDA Staff Chief Joins Hogan Lowells

Former FDA chief of staff Elizabeth Jungman joins law firm Hogan Lovells as a partner in its pharmaceuticals and biotechnology practice in the Washing...