Latest Federal Register Notices
Guide on Special 510(k) Program
Federal Register notice: FDA makes available a final guidance entitled “The Special 510(k) Program.” 09/13/2019
FDA Posts 9 OMB-approved Info Collections
Federal Register notice: FDA posts a list of ninee information collections that have been approved by OMB. 09/13/2019
Science Board to Discuss CBER Research
Federal Register notice: FDA announces a 10/7 Science Board meeting to hear CBER’s response on its research program. 09/12/2019
Hearing on Fecal Microbiota for Transplantation
Federal Register notice: FDA announces an 11/4 public hearing to obtain input on the use of fecal microbiota for transplantation to treat Clostridium difficile infection. 09/12/2019
Regulatory Review Period for Edwards Aortic Bioprosthesis
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Edwards Lifesciences’ Pericardial Aortic Bioprosthesis. 09/12/2019
Calcimar Not Withdraw Due to Safety/Efficacy
Federal Register notice: FDA determines that Sanofi Aventis’ Calcimar (calcitonin salmon) injection, 200 IU/mL was not withdrawn from sale due to safety or effectiveness reasons. 09/11/2019
Aegea Vapor System Regulatory Review Period
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Tsunami MedTech’s Aegea Vapor System, indicated for ablation of the endometrial lining of the uterus. 09/11/2019