FDA tells Liquidia Corp. that its earlier user fee review action target date of 1/24 will be missed on the companys NDA for Yutrepia (treprostinil) in...
A Sheppard Mullin report describes several FDA issues that life sciences companies can expect to face in 2024.
FDA issues a finalized guidance on updating ANDA labels following revisions to the reference-listed drug label.
CDER and CBER say they have accepted the first artificial intelligence, digital health technology, and neuroscience project in the ISTAND pilot for de...
FDA publishes a comprehensive Veterinary International Conference on Harmonization guidance on good manufacturing practice for animal drug APIs.
FDA purchases a subscription to digiM Solutions I2S software for the CDER Division of Product Quality and Research.
Five stakeholders suggest possible topics for an upcoming FDA workshop on innovative drug clinical trials.
Twenty-eight non-profit groups representing the CBD (cannabidiol) and hemp industries call on Congress to hold a hearing to understand the agencys app...
