Lexology January 17, 2025
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be no exception to this rule, and with its arrival we examine FDA’s activities in 2024 in the drug development space with an eye toward what 2025 may bring us, ranging from administrative changes at the US Food and Drug Administration (FDA), issues of clinical trial design and drug development, expedited programs, to Hatch-Waxman Act considerations.
As we have previously written, the ongoing change in presidential administration is poised to have impacts at FDA. While generally the vast majority of FDA staff remain unchanged through these transitions, a number of appointed positions typically change between administrations....
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