President Obama signs into law the 21st Century Cures Act, which will provide a $500 million funding boost for FDA over the next 10 years to help with...
FDA selects Department of Justice Office of International Affairs attorney Donald D. Ashley as CDERs next Office of Compliance director, effective 1/9...
FDA finalizes a guidance on Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals) that describes CDRHs policy for notif...
A CDRH conference call clarifies when medical device firms are required to file Medical Device Reporting submissions and answers questions pertaining ...
Federal Register Notice: FDA seeks comments on a new information collection related to Donor Risk Assessment Questionnaire for FDA/National Heart, Lun...
Federal Register Notice: FDA determines the regulatory review period for patent extension purposes of GlaxoSmithKlines Nucala (mepolizumab) for use wi...
Federal Register Final Rule Correction: FDA corrects a final rule entitled Requirements for Foreign and Domestic Establishment Registration and Listin...
FDA approves a Vericel PMA for Maci (autologous cultured chondrocytes on porcine collagen membrane) for repairing symptomatic, full-thickness knee car...