In June 2021 FDA published an important Draft Guidance, Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies:CLICK HERE FOR FDA DOCUMENT
This is a significant step towards defining new expectations FDA has for industry, and clarifying some existing expectations. Sponsors need to be prepared and incorporate appropriate actions into strategic plans for 2022 and beyond.
MedAssessment specializes in Clinical Safety and Pharmacovigilance in early development, so is in a unique position to explore this Draft Guidance and invite other industry thought leaders into this important discussion.
Throughout Q4 2021 MedAssessment held a series of open and public “Brainstorming Pharmacovigilance” thought leadership groups, during which we talked with other industry experts and peers about the following:
- What do sponsors need to do differently as a result of this Draft Guidance, and in what timeframe?
- Is there a greater impact on small sponsors than large, if so, in what ways?
- What other departments, outside of Pharmacovigilance, will be impacted by this Guidance?
- What should people outside of PV expect to see from PV or be required to do as a result of this Guidance?
- What is the anticipated timeframe for Guidance finalization, and what implications?
- How is CRO oversight impacted by this new guidance?
- History of this Guidance- how did we get to this point?
- What is the impact of this Guidance on ex-US PV activities?
- What is the requirement for epidemiology studies?
- How should sponsors handle the aggregate data
- Addressing clinical vs. statistical significance in early development/small sample sizes
- And more!