FDA approves a Kalo supplemental NDA for AUVI-Q (epinephrine injection, USP) 0.1 mg, for treating life-threatening allergic reactions, including anaph...
FDA approves a Medtronic PMA for its Azure pacemakers with BlueSync technology.
Federal Register notice: FDA extends its comment period provided in a 7/31 Federal Register notice entitled Cardiac Troponin Assays; Public Workshop; ...
Federal Register notice: FDA seeks comments on a petition from an undisclosed applicant requesting exemption from premarket notification requirements ...
Federal Register notice: FDA makes available a guidance on Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding ...
Federal Register notice: FDA makes available a guidance entitled Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Pro...
FDA grants PellePharm a breakthrough therapy designation and orphan drug designation for topical patidegib for patients with Gorlin Syndrome.
FDA Review posts the Federal Register notices for the week ending 11/17/2017.