PDUFA VI Public Hearing

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In mid-July, FDA held a public hearing for input on the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI). The meeting began with opening remarks from FDA’s Acting Commissioner Stephen Ostroff. Afterward, various stakeholders, in-cluding the Pew Charitable Trusts, National Organization for Rare Disorders (NORD), the Pharmaceutical Research and Manu-facturers of America (PhRMA), the Biotech Industry Organization (BIO) and the Alliance for Regenerative Medicine (ARM), pre-sented their views on PDUFA, including responses to the following questions posed by the agency prior to the meeting: ● “What is your assessment of the overall performance of PDUFA V thus far?” ● “What current features of PDUFA should be reduced or discontinued to ensure the continued efficiency and effectiveness of the human drug review process?” ● “What new features should FDA consider adding to the program to enhance the efficiency and effectiveness of the human drug review process?” [For a review of the IPEC-Americas comments on PDUFA advocating for an excipient safety review pathway, see the story on pp. 28-43.]
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