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Federal Register

Guide on Drug Labeling About Child Packaging

Federal Register notice: FDA makes available a final guidance entitled Child-Resistant Packaging Statements in Drug Product Labeling.

Medical Devices

Post Questions FDA Role in AI/ML Oversight

Forbes Technology Council member Charles Aunger questions whether FDA is able to provide needed oversight of artificial intelligence/machine learning-...

Federal Register

Mammography Quality Assurance Advisory Panel Renewal

Federal Register notice: FDA renews the National Mammography Quality Assurance Advisory Committee for an additional two years.

Federal Register

Comments Sought on Device Q-Submission Program

Federal Register notice: FDA seeks comments on an information collection extension for its Q-Submission Program for Medical Devices (OMB Control Numbe...

Human Drugs

Revised Guide Gastroparesis Drug Development

FDA revises a 2015 draft guidance on Gastroparesis: Clinical Evaluation of Drugs for Treatment.

Federal Register

Info Collection Extension for Device Accessories

Federal Register notice: FDA sends to OMB an information collection extension for its guidance on medical device accessories.

Drug Recalls Down, Units Up

The Stericycle Recall Index says drug recalls are dropping but the number of recalled units is increasing, while medical device recalls and units are ...

Human Drugs

FDA Inactivating Some Drug Listing Records

FDA says it will start inactivating drug listing records that are improperly listed according to agency requirements.

Medical Devices

QS Violations in Talon Inspection

FDA warns Talon about Quality System and other violations in its production of Class 1 and 2 medical devices.

Human Drugs

CGMP Violation in Emcure Inspection

FDA warns Indias Emcure Pharmaceuticals about a CGMP issue in its production of finished pharmaceuticals.