FDA Related News

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.

Human Drugs

Nurix Therapeutics Gets Fast Track Status

FDA grants Nurix Therapeutics a fast track designation for NX-5948 for treating certain adult patients with relapsed or refractory chronic lymphocytic...

Federal Register

Info Collection on New Dietary Ingredients

Federal Register notice: FDA revises an information collection entitled Premarket Notification for a New Dietary Ingredient (NDI) 21 CFR 190.6.

Medical Devices

Multiple Violations at Dr. Joel Kaplan Inc.

FDA warns San Diego, CA-based Dr. Joel Kaplan Inc. about multiple violations in its manufacturing and distribution of several devices intended to enha...

Docs Dont Understand FDA Approval Process: Research

A physician survey conducted by UCSF researchers finds many doctors dont understand how FDA approves new drugs and medical devices.