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Northwestern University details research in oncology.

Publication: Medical Letter on the CDC & FDA
Publication Date: 25-OCT-09
Format: Online
Delivery: Immediate Online Access

Article Excerpt
According to recent research from the United States, "Accelerated approval (AA) was initiated by the US Food and Drug Administration (FDA) to shorten development times of drugs for serious medical illnesses. Sponsors must confirm efficacy in postapproval trials."

"Confronted with several drugs that received AA on the basis of phase II trials and for which confirmatory trials were incomplete, FDA officials have...

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