Posted by pseudoname on October 8, 2006, at 15:29:49
In reply to Re: more recent data (same times) » pseudoname, posted by yxibow on October 8, 2006, at 14:53:21
Thanks, Jay. I just found this:
<quote>
A Priority designation is intended for those products that address unmet medical needs.The drug product, if approved, would be a significant improvement compared to marketed products […]. Improvement can be demonstrated by, for example: (1) evidence of increased effectiveness in treatment, prevention, or diagnosis of disease; (2) elimination or substantial reduction of a treatment-limiting drug reaction; (3) documented enhancement of patient compliance; or (4) evidence of safety and effectiveness of a new subpopulation.
The priority determination does not take into consideration any information or estimate of price and is based on conditions and information available at the time the application is filed. It is not intended to predict a drug’s ultimate value or its eventual place in the market.
<unquote>[Also, drugs can change mid-evaluation from "Priority" to "Standard".]
• http://www.fda.gov/cder/mapp/6020-3.pdf
It seems like anything but a me-too drug should get Priority, under those definitions. And there's also Fast Track, which is completely different process, and Accelerated Approval, which I have no idea what is.
poster:pseudoname
thread:692938
URL: http://www.dr-bob.org/babble/20061003/msgs/693069.html