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.
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Current record: $507,000. Proceeds to go to LLS as NIH funding is slashed - Amid HHS upheaval, Bhattacharya takes the helm at NIH, Makary at FDA
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Former FDA Commissioner Scott Gottlieb expresses “deep concerns” - In The Headlines: Private funding can’t replace federal funding—but it can help
