FDA Related News

Medical Devices

Electa Instrument Recalls Biopsy Needle Kits

Elekta Instrument AB recalls (Class 1) its Elekta Disposable Biopsy Needle Kit for the Leksell Stereotactic System due to microscopic debris found on ...

FDA General

How Soon Will Trump Nominate Next FDA Head?

FDA watchers need patience as they wait to see who president-elect Donald Trump chooses to nominate as the next FDA commissioner.

IRB Violations Seen in FDA-483s

FDA identifies four trends in IRB violations from FDA-483s issued in FY 2023.

Human Drugs

Public Citizen Blasts Potential Drug Approval Change

Public Citizen preemptively criticizes expected 2025 legislation to authorize FDA to approve drugs for rare diseases based on substantial evidence rat...

Federal Register

FDA Ban on Phenylephrine in Nasal Decongestants

Federal Register notice: FDA issues a proposed administrative order to remove orally administered phenylephrine in OTC nasal decongestants.

Medical Devices

Poor Training Found in Lab Inspections

FDA cites a lack of adequate training in FY 2023 Good Laboratory Practice inspection form FDA-483s.

Medical Devices

FDA Approves J&J Varipulse Platform

FDA approves the J&J Varipulse pulsed field ablation platform to treat atrial fibrillation.

Human Drugs

Sarepta Scraps Next-Gen Duchenne Drug

Based on safety concerns, Sarepta says it is discontinuing the development of SRP-5051 (vesleteplirsen) for treating patients with Duchenne muscular d...

Human Drugs

9 Observations in Staska Pharmaceuticals FDA-483

FDA releases the form FDA-483 with nine observations from an inspection at the Staska Pharmaceuticals outsourcing facility in Bennet, NE.

Human Drugs

Clozapine REMS Curbs Treatment: Comments

Three mental health stakeholders call on two FDA advisory committees to recommend changes to the clozapine REMS.