FDA Related News

Medical Devices

Lifecycle Recommendations for AI-Enabled Devices

FDA publishes a draft guidance with recommendations on lifecycle management and marketing submissions for AI-enabled medical device software functions...

Sex Differences in Clinical Evaluations of Products

FDA publishes a draft guidance intended to improve the representation of females in medical product clinical trials.

Biologics

RSV Vaccines Get Guillain-Barr Warning

FDA requires safety labeling changes about Guillain-Barr syndrome risks for Pfizers Abrysvo (respiratory syncytial virus vaccine) and GlaxoSmithKline ...

Medical Devices

Guide on Device Supply Interruption Notifications

FDA posts a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the...

Human Drugs

Guide on Seeing if Confirmatory Study Underway

FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.

Medical Devices

Inogen Airway Clearance Device Cleared

FDA clears an Inogen 510(k) for the Simeox 200 Airway Clearance Device.

Human Drugs

FDA OKs Galderma Dermatitis Drug Nemluvio

FDA approves Galdermas Nemluvio to treat some dermatitis patients aged 12 and older.

Human Drugs

Alcon Recalls Systane Ultra PF Eye Drops

FDA says Alcon recalled one lot of Systane Ultra PF eye drops due to potential fungal contamination.

Human Drugs

FDA OKs Arrays Braftovi for Some Cancers

FDA approves Array BioPharmas Braftovi to treat some patients with metastatic colorectal cancer with a specific mutation.

Human Drugs

Ionis Spinraza Approved by FDA for SMA

FDA approves Ionis Spinraza as the first drug approved to treat children and adults with spinal muscular atrophy.