Roundtable Discussion: Evaluating Regulators’ Views on Safety & Toxicity Testing to Streamline Preclinical Testing & Fast-Track RNA-Targeting Drug Approval
Time: 9:30 am
day: Focus Day
Details:
- What are regulators' thoughts on using animal models to showcase off-target effects and toxicity given their limited RNA conservation?
- What safety and toxicity tests are required to gain FDA approval for advancing into human clinical trials?
- Highlight specifications which are required to be met by RNA-targeting drugs to ensure regulatory approval
