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AI-Assisted Chest X-ray Cleared

[ Price : $8.95]

FDA clears an Envisionit Deep AI 510(k) for its artificial intelligence (AI)-assisted chest x-ray device, Radify Triage, for triag...

Details on 22 Covid EUAs from 2023

[ Price : $8.95]

Federal Register notice: FDA announces the issuance of Emergency Use Authorizations for 22 medical Covid-related medical devices a...

Guide on GMPs for Veterinary APIs

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Good Manufacturing Practice for Active Pharmaceutical Ingre...

Vitacell Biologics Illegally Selling Cellular Products: FDA

[ Price : $8.95]

CBER says Lewisburg, TN-based Vitacell Biologics is illegally marketing cellular and exosome products.

STAQ Pharma of Ohio FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with two inspection observations issued to Columbus, OH-based STAQ Pharma of Ohio.

22 T-Cell Cancers After CAR-T Treatment: CBER

[ Price : $8.95]

CBER executives say FDA is aware of a relatively small number of cases in which people treated with CAR-T products developed secon...

Final ANDA Label Revision Guidance

[ Price : $8.95]

FDA issues a finalized guidance on updating ANDA labels following revisions to the reference-listed drug label.

1st ISTAND Pilot AI Submission Accepted

[ Price : $8.95]

CDER and CBER say they have accepted the first artificial intelligence, digital health technology, and neuroscience project in the...

Animal Drug API GMP Guidance

[ Price : $8.95]

FDA publishes a comprehensive Veterinary International Conference on Harmonization guidance on good manufacturing practice for ani...

FDA Subscribes to digiM I2S Software

[ Price : $8.95]

FDA purchases a subscription to digiM Solutions I2S software for the CDER Division of Product Quality and Research.