Federal Register notice: FDA proposes a new information collection on Providing Regulatory Submissions in Electronic and Non-Electronic Format Promot...
FDA releases a list of 40 angiontensin II receptor blockers that it has determined to be nitrosamine-free.
FDA approves a Pfizer supplemental NDA for Ibrance (palbociclib) capsules and its use in combination with specific endocrine therapies for certain typ...
FDA accepts for review a Kyowa Hakko Kirin resubmitted NDA for KW-6002 (istradefylline), an investigational selective adenosine A2A receptor antagonis...
FDA extends by three months the review of a Daiichi Sankyo NDA for quizartinib, an investigational FLT3 inhibitor currently under priority review for ...
Federal Register notice: FDA announces a 5/31 public hearing to obtain scientific data and information about products containing cannabis or cannabis-...
Federal Register notice: FDA seeks comments on an information collection extension related to its Guidance: Emergency Use Authorization of Medical Pro...
Federal Register notice: FDA seeks comments on an information collection extension related to a guidance entitled Medical Device Accessories.