Federal Register notice: FDA joint advisory committee meeting reviews Indivior Pharmaceuticals NDA for buprenorphine subcutaneous injection and its us...
Federal Register notice: FDA seeks public input on the design of its REMS Platform Standards Initiative, as well as methods and best practices.
The HHS Inspector General says that seven recalled or prematurely failed cardiac devices cost Medicare $1.5 billion over nine years.
FDA commissioner Scott Gottlieb flies to Puerto Rico 9/29 to see firsthand the devastation caused by Hurricane Maria.
Federal Register notice: CDER announces support for version 1.1 of Clinical Data Interchange Standards Consortium, Analysis Data Model Implementation ...
Federal Register notice: FDA announces a 10/6 public workshop entitled Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: ...
FDA reminds medical device makers about the beginning of National Cybersecurity Awareness Month and to remain constantly vigilant about potential vuln...
FDA makes available a guidance on Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Admi...