Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
The United States built a rigorous system over decades to protect patients from harm while receiving new types of medical treatment. New drugs and new vaccines, in particular, have been barred from widespread use until they...more
For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,”...more
The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more