Topic
In June 2021 FDA published an important Draft Guidance, Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: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 DOCUMENTThis is a significant step towards defining a new paradigm and clarifying some existing expectations that FDA has for industry.
As specialists in Clinical Safety and Pharmacovigilance in early development, MedAssessment is in a unique position to explore this Draft Guidance and invite other industry thought leaders into this important discussion.
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- What do sponsors need to do differently as a result of this Draft Guidance, and in what timeframe?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!
