Pharmacy organizations support provisions in FDA agreement that would promote use of real-world evidence
Congress won’t reauthorize the Prescription Drug User Fee Act until 2017, but APhA and other pharmacy organizations expressed satisfaction with FDA-proposed provisions that would enhance the use of real-world evidence in decisions that affect the content of guidances on key pharmaceutical issues—in this case, the process for prescription drug approval and postmarket evaluation. PDUFA authorizes FDA to collect fees from biopharmaceutical companies to subsidize the agency’s process for reviewing new drugs and biologics.
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