The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more
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...more
The US Food and Drug Administration (FDA) was busy in 2023 with significant, and even bullish, developments occurring across several areas, from drug and biologic development and manufacturing to labeling, advertising, and...more