Alas, where has the week gone to? It is time for the weekly round up. As scandal breaks in our nation’s city, and the Congress is in a scramble right at election time, we inside the Beltway are wondering what you outside the Beltway are going to do. In the meantime, here at Eye on FDA, we mind our own business:
- Congressional Budget Office Report – The CBO has released a report on Research and Development in the Pharmaceutical Industry. Check it out.
- Workshop Being Announced for Nov 13 on Critical Path – Even though the workshop on Adaptive Clinical Trials has not been posted anywhere, on Monday the Federal Register will carry notice of another workshop for the same day as was proposed for the Adaptive Clinical Trials workshop, but this one is a Workshop on Sex Differences and the Critical Path Initiative. Go figure. It will be held at the Mayflower Hotel from 9-5 that day.
- Consent Decree Entered – The agency announced a Consent Decree with several companies respecting unapproved drug distribution.
- New Improved HIV Test – The agency also announced a new HIV Test manufactured by Gen-Probe. This development coincides with a recommendation by CDC that Americans be routinely screened for the virus. The test purportedly will find evidence of the virus at an earlier stage.
- Telling the Difference Between Fast Track and Accelerated Approval – People constantly mix these things up, so I wanted to put you in touch with a page that defines it all for you at the FDA Web site. This will tell you all the differences and requirement of Fast Track, Accelerated Approval and Priority Review.