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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.

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

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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

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

Theratechnologies Complete Response on Tesamorelin

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

Info Collection on Radiopharmaceuticals

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