User Fee Conference Committee Targets Settling Differences In June
This article was originally published in The Tan Sheet
A conference committee tackles differences between House and Senate FDA user fee and agency reform bills, with an agreement expected before the end of June.
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Institute of Medicine report recommends how FDA, industry and other stakeholders can strengthen food and drug regulatory systems abroad. It calls for FDA to provide incentives for foreign regulators to meet U.S. standards and facilitate training and for the government to help hold importers liable.
House drafters’ dissatisfaction with FDA’s performance is evident in several provisions of draft user fee legislation. The agency would be required to finalize some guidances within a year of issuing a draft, which likely would provide more predictability for industry.
Congress should allow the agency to determine which drug-resistant bacteria sponsors should target in order to earn incentives for antibiotic development, rather than list specific pathogens, CDER Director Janet Woodcock suggested to a House panel March 8. The window to change the GAIN Act appears to be closing, though.