FDA publishes three guidances describing the effect on the review clock and goals of agency and industry actions in de novo, 510(k), and PMA submissio...
FDA grants Calithera Biosciences a fast track designation for mTORC 1/2 inhibitor sapanisertib (CB-228) for treating certain adult patients with unres...
FDA posts a draft guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.
FDA releases a final guidance entitled Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.
FDA grants approval for a Taiho Oncology NDA for Lytgobi (futibatinib) for treating certain adult patients with bile duct cancer.
FDA sends India-based drug maker Lupin a Warning Letter after inspecting its Tarapur, Maharashtra facility 3/22 to 4/4.
FDA expands CDERs NextGen Portal to enable certain electronic over-the-counter monograph submissions under section 505G of the Federal Food, Drug, and...
FDA adds important information to the emergency authorization of AstraZenecas Evusheld to inform health care providers and individuals about the incre...
