Podcast 1: FDA in Transition: How Regulatory Shifts Are Redefining Drug Development
The uncertainty surrounding changes at the FDA and other market dynamics is reshaping the global drug development landscape. In the opening episode, CRO regulatory leaders summarized the collective experience and insights gathered from their conversations with biotech companies navigating this shifting environment. They explored:
- The impact of the FDA leadership changes, staffing cuts, and return to office mandates in reshaping regulatory priorities.
- Trends they’ve observed from biotech sponsors on the decision of whether or not to keep trials in the US.
- The broader implications for industry investment, pipeline prioritization strategies, and international responses.
This is the first episode in a four-part series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials", featuring insights from Novotech on evolving trends impacting global clinical development. Don’t miss the next episode, where we’ll continue exploring the key forces shaping the future of clinical trials.