FDA published a “goals letter” outlining the performance goals and procedures for the Over-the-Counter Monograph Drug User Fee Act (OMUFA) initial program. Industry, public stakeholders, and FDA reached an agreement on the principles of a system of monograph user fees to enable a range of additional review activities necessary to meet the goals of monograph reform, such as: ● hiring and training of FDA personnel ● implementation of an information technology platform, and ● other innovations and timelines.
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