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FDA makes available a draft guidance on Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.
FDA releases two guidances as part of its initiative to make it easier to introduce generic copies of complex drugs.
FDA posts a guidance on Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A.
FDA releases a guidance on Display Devices for Diagnostic Radiology that is intended to assist industry in preparing premarket notification submission...
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 ...