FDA posts a guidance on De Novo Classification Process (Evaluation of Automatic Class III Designation) that provides recommendation on how to use the ...
FDA issues a final guidance document entitled Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients upon Request.
Federal Register: FDA seeks comments on an information collection extension related to a guidance on formal dispute resolution on drug GMP issues.
FDA posts a guidance entitled: Product Labeling for Certain Ultrasonic Surgical Aspirator Devices that describes the agencys current thinking on such ...
FDA clears a Nitiloop 510(k) for the Nova Cross Extreme and Nova Cross BTK, dedicated microcatheters for use in conjunction with conventional guidewir...
FDA approves a Tesaro supplemental NDA for Varubi (rolapitant) IV in combination with other antiemetic agents in adults for preventing delayed nausea ...
Federal Register notice: FDA makes available a guidance entitled Deciding When to Submit a 510(k) for a Change to an Existing Device that clarifies wh...
Achaogen files an NDA for plazomicin, indicated for treating complicated urinary tract infections.