by Pill Pals | Sep 11, 2024 | News
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Christopher K. Cote , Kevin D. Mlynek, Christopher P. Klimko, Sergei S. Biryukov, Sherry Mou,...
by Pill Pals | Sep 11, 2024 | News
8/29/2024 AbbVie, Inc. UBRELVY (ubrogepant) tablets, for oral use None None 8/1/2024 Mirati Therapeutics Inc., a Bristol Myers Squibb Co. NDA 216340, KRAZATI™ (adagrasib) tablets, for oral use None None 7/17/2024 Kaleo, Inc. NDA 201739, AUVI-Q (epinephrine injection,...
by Pill Pals | Sep 11, 2024 | News
Publish Draft, Revised, or Final Guidance on Digital Health Technologies Enhancing Use of Digital Health Technologies to Support Drug Development and Review 12/21/2021 Launch Rare Disease Endpoint Advancement Pilot Program Advancing Development of Drugs for Rare...
by Pill Pals | Sep 11, 2024 | News
Docket Number: FDA-2017-D-5670 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to explain to applicants how the assessment goals established as part of the Generic Drug User Fee Amendments of 2022 (GDUFA III) apply...
by Pill Pals | Sep 11, 2024 | News
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Lauren Jansen, Rachael Birn2, Samir Koirala, Sadie Oppegard3, Brianna Loeck, Jeff Hamik,...
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