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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.

Stakeholder Input on Innovative Trial Workshop

[ Price : $8.95]

Five stakeholders suggest possible topics for an upcoming FDA workshop on innovative drug clinical trials.

Groups Urge Hearing on CBD Regulation

[ Price : $8.95]

Twenty-eight non-profit groups representing the CBD (cannabidiol) and hemp industries call on Congress to hold a hearing to unders...

ANDA Final Approval Guidance

[ Price : $8.95]

FDA publishes an updated guidance incorporating GDUFA 3 performance goals on amendments and requests for final approval to tentati...

Theratechnologies Complete Response on Tesamorelin

[ Price : $8.95]

FDA sends Theratechnologies a complete response letter on its supplemental BLA for an F8 formulation of Egrifta SV (tesamorelin), ...

Info Collection on Radiopharmaceuticals

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Regulations for In Vivo Radiopharmaceutical...

4 Priority Review Vouchers Redeemed: FDA

[ Price : $8.95]

Federal Register notices: FDA posts four announcements about a priority review voucher being redeemed as part of a product approva...

CDRH Tech Innovation Group Now a Super Office

[ Price : $8.95]

CDRH says its Office of Strategic Partnerships and Technology Innovation has been elevated to a super office.