backThe FDA recently pivoted to a more patient-focused approach to clarify its approval process for expanded access ("compassionate use") of investigational drugs and make it less burdensome. In June 2016, the Agency adopted a new and simplified process for physicians to seek FDA approval for single patient expanded access, and it finalized three guidance documents to clarify, among other things, charging for investigational drugs. This Webinar will:
- Step through FDA's new guidance, with a focus on the new streamlined approach for single patient expanded access and its implications for pharmaceutical manufacturers.
- Frame FDA's actions in the context of the larger policy debate about "right to try," including the impact of social media and independent ethics panels.
- Discuss the challenges and barriers of successfully operating expanded access programs, including risks around program administration and hurdles for charging for investigational drugs.
- Address why these initiatives may heighten expectations that manufacturers will provide investigational drugs for compassionate use, and explore how manufacturers should prepare.
You do not have to be a client to attend, and there is no charge.
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Questions
If you have questions concerning this Roundtable Webinar, e-mail lifesciences-healthcare@kslaw.com.