Bloomberg
Bloomberg.com reported on drugmakers that win early U.S. approval of promising cancer treatments may face fines up to $10 million if they take too long to confirm effectiveness in follow-up studies. The FDA may also start requiring that such trials be underway before a drug can win expedited approval, according to a report published online in the Journal of the National Cancer Institute. The amount of time saved through the accelerated-approval process isn’t clear from the FDA officials’ report, stated Susan Ellenberg, PhD, professor of Biostatistics, in an accompanying editorial. The regular drug-approval process could take less time than the separate sets of initial studies and follow-ups required for an accelerated approval, she said... Read More
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