FDA Related News

Human Drugs

Package Level Drug Distribution Security Guidance

FDA publishes a guidance on enhanced drug distribution security at the package level.

Human Drugs

Satsuma Complete Response on Migraine Drug

FDA sends Satsuma Pharmaceuticals a complete response letter on its NDA for STS101 (dihydroergotamine nasal powder), an investigational product for th...

Medical Devices

Percussionaire Recalls Ventilator Part

Percussionaire recalls its Distal Phasitron, part: S20020, for use with the Percussionaire VDR-4 ventilator control driver due to the potential for th...

Medical Devices

Megadyne Mega Soft Electrode Recall is Class 1

FDA says the Megadyne recall of four models of patient return electrodes following reports of patient burns is Class 1.

Medical Devices

GAO Probing FDA Ventilator Recall Actions

The Pittsburgh Post-Gazette says GAO has accepted a request from two senators to look into FDA oversight of medical device adverse events and recalls.

Medical Devices

Reducing the Potential for Pulse Oximeter Bias

Two stakeholders raise concerns about an FDA discussion paper on guidelines for pulse oximeters that consider skin pigmentation, race, and ethnicity.

FDA Needs Help in Regulating Algorithms: Califf

FDA commissioner Robert Califf says FDA needs to work within a community of organizations assessing and evaluating artificial intelligence adaptive to...

Human Drugs

DermaSensor AI Skin Cancer Detector Cleared

FDA clears DermaSensor's real-time, skin cancer evaluation system.

Human Drugs

FDA Extends Narcan Shelf Life

FDA extends the shelf life of Emergent BioSolutions newly manufactured Narcan (naloxone HCl) 4 mg nasal spray products from three years to four years....

Human Drugs

Reschedule Marijuana to Schedule 3: FDA

FDA recommends that the Drug Enforcement Administration down-classify marijuana from Schedule 1 to Schedule 3 under the Controlled Substances Act.