FDA approves a new cancer drug, Vidaza, and two sNDAs, without going to ODAC. A date with ODAC may signal a weak case for drug approval, recent approval data indicate.
Also in this 8-page issue: Cooperative groups tell Congress that NCI’s $115 million in support for adult cancer clinical trials is “chump change.” Trials would close faster, report results sooner, if funding were increased, regulatory issues streamlined.
Larry Norton wins ASCO’s Karnofsky award.
Funding opportunities listed.
May issue of Business & Regulatory Report, 8 additional pages, included.
Trending Stories
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- NIH eliminates the NCI Board of Scientific Advisors
Over its 28 year history, BSA shaped NCI-funded extramural science - In The Headlines: Increasing incidence of early-onset cancer is “a paradigm shift oncology isn’t quite prepared for”
- Makary: Level of evidence is an artificial and dogmatic construct