FDA Related News

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...

IRB Violations Seen in FDA-483s

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

Medical Devices

FDA OKs LumiThera Dry AMD Treatment

FDA grants de novo authorization to LumiTheras Valeda light delivery treatment for dry age-related macular degeneration.

Human Drugs

Caris Companion Diagnostic for Cancer Approved

FDA approves Caris Life Sciences MI Cancer Seek and its use as a companion diagnostic to identify cancer patients for treatment with several targeted ...

Medical Devices

ACLA Views on PCCP Draft Guidance

The American Clinical Laboratory Association submits comments to an FDA draft guidance on medical device predetermined change control plans.

FDA General

RFK Jr. Says Some FDA Departments Have to Go

In an interview the day after the election, president-elect Donald Trumps top health advisor Robert F. Kennedy Jr. says there are some FDA departments...

Medical Devices

Breakthrough Designation for SeaStar Dialysis Device

FDA grants a fourth breakthrough device designation for SeaStar Medicals Selective Cytopheretic Device.