Agency previously pointed to pending litigation as reason for punting . . .

FDA Won't Say Whether It Will Weigh In On Biosimilar Pathway Ruling

June 22, 2017 at 8:36 PM
FDA will not say whether it will answer a call from Supreme Court Justice Stephen Breyer for the agency to craft its own interpretation of the biosimilar pathway. Two FDA sources, including the agency's head of biosimilars, declined to answer Inside Health Policy 's question whether the agency will engage in rulemaking to further lay out the pathway. The agency previously was petitioned to weigh in and denied the request because of pending litigation -- but now that the legal...


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