Expedited Approval Pathway Concept Draws Strong Support But Different Proposals
This article was originally published in Pharmaceutical Approvals Monthly
Debate at a recent cancer research meeting reflects the challenges that lay ahead, and the diverging viewpoints that will have to be balanced, in creating any new approval mechanism.
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FDA approved Pfizer’s lung cancer drug for patients positive for the gene translocation – but review documents show that agency reviewers focused on the efficacy seen in the few ALK-negative patients in the pivotal trial, and want Pfizer to follow up on that signal post-marketing. Regulatory expectations for disproving effect in the non-selected population will be an important issue as more personalized medicines reach the agency.
CDER Director Woodcock says agency should issue internal and external guidance to promote consistent use of the pathway.
Legislation being drafted by Sen. Kay Hagan, D-N.C., would formalize FDA practices of approving drugs in certain circumstances where the evidence needed for a standard approval cannot be generated.