[schoonder]

http://southshorexpress.com/whitman-...ncer-drug.html

A recent WSJ article reported new FDA programs are being implemented by FDA Commissioner Margaret Hamburg to make the approval process clearer and more predictable for applicants. In particular elements in need to be improved upon were:.

1 - Timelines are long.
2 - Lack of clarity and consistency from FDA reviewers.
3 - Early dialogues between company founders and the agency will help smooth the regulatory process.
4 - New emphasis on personalized medicine, a burgeoning area that needs an updated approval strategy.
5 - Expedited drug development pathway for drugs that target threatening conditions and illnesses for which there is no great alternative already on the market.
6 - Unpredictability at the FDA.

http://blogs.wsj.com/venturecapital/2011/10/05/fda-tries-to-mend-fences-with-med-tech-start-ups-investors/?mod=google_news_blog
Since drug approval process is so closely tied to actual life and death issues, one would think Congressional Oversight Committee would assure immediate steps be taken to set right what now has been accepted to be a somewhat flawed approval practice, especially with personalized (targeted) medicine.
The T-DM1 refuse to file letter send to Genentech IMO was a direct consequence of a number of the shortcomings identified in that WSJ article.
There’s little to no risk involved for FDA to retract that RTF decision and to instantly start with examination of T-DM1 phase II results. Roche and partners are currently conducting THREE large, international phase III trials in 1st, 2nd and 3rd line HER2+ MBC setting. These data results when they are filed, the 2nd line study expected to complete by mid-2012, will guide FDA in further decision making.