Posted by Steve Santen on January 09, 1998 at 11:48:44:
In Reply to: Outline: U.S. Government/Federal Agencies posted by Robin Harrison on January 09, 1998 at 10:44:56:
Robin:
An excellent outline, thanks. I continue to have a question though. Encapsulated islets (porcine or human) would require CBER review and eximination because the islets are considered biologics. Which agency would be responsible for the approval of the encapsulation device? Is there another subagency that would also play a role because of the encapsulation involved? If so, who coordinates final approval? Is this done at a higher level?
Still confused. Steve