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Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program
The Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program is designed to expand DDT types by e...
FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma
On March 22, 2023, the Food and Drug Administration granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte Corpo...
Electronic Systems, Electronic Records, and Electronic Signatures Webinar - 04/25/2023
In this webinar, FDA will present the current thinking regarding 21 CFR 11 and its application to electronic records, elec...