Zdrowie i gospodarka · 08/03/2013

FDA Requests Public Comment on Benefit-Risk Plan for Prescription Drugs

The Food and Drug Administration (FDA) is seeking public comment on a draft 5-year plan outlining its approach to benefit-risk assessment in the review process for human drugs and biologics, as part of the Prescription Drug User Fee Act (PDUFA V). The plan is available for review on the FDA's website at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf.