Also at the FDA/CMS conference, CDER Director Janet Woodcock outlined the center’s ongoing initiatives and 2018 priorities, such as: • implementing center-wide informatics and the CURES legislation • administering the reauthorized biolsimilar, generics, and prescription drug use fee legislation (BSUFA/GDUFA/PDUFA) to meet goals • improved hiring • treating opioid use disorder • compounding regulation • new drug program modernization, and • OTC monograph reform.
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