To date, 37 states within the US have “Right to Try Laws” in place. “Right to Try” laws allow terminally and severely ill patients to try medicines that have passed the first phase of the FDA/Health Authority approval process, but have not been fully approved for public use. On a federal level, a version of the Right to Try Law (Bill H.R.878) was introduced to the House of Representatives with bipartisan support. The opportunity to have your promising therapy available to assist patients and gather real-time clinical data is very exciting. However, you must understand the laws and map your Right to Try programs on a risk-mitigated compliance path.
This webinar will discuss how you can maintain compliance while treating patients under the Right to Try Laws. By attending this 90-minute interactive session, you will learn:
- Current status and meaning of the “Right to Try” Laws
- Specific requirements for implementation and compliance by the Sponsor, Investigator, and Patient
- Specific risks to Sponsor and Investigator
- How to gather meaningful “Right to Try” data and what to do with it
- The impact on the Marketing Authorization process