The U.S. Supreme Court asks the government to weigh in on Tevas appeal of a court decision in a case involving a so-called skinny label for a generic ...
FDA says device makers can now send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions online throug...
FDA and other researchers tout the benefits of the accelerated approval pathway in precision oncology.
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FDA posts a draft guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.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.
