Issues surrounding off-label dissemination may be clarified through regulations required by the FDA Amendments Act of 2007
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The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.
