What is the ASAP and what you should know about it
- The US FDA has been advocating for aggregate program-level safety evaluations since 1988 when the ISS was introduced (the IND Safety Reporting Final Rule).
- Aggregate data analysis looks at all available data holistically rather than relying on individual case reports. This allows for a more complete understanding of potential risks associated with a drug or vaccine.
- In the near future, more companies will adopt a systematic approach to aggregate safety assessment planning and IND safety reporting.
- This process will develop a better understanding of the safety profile of drugs and ensure that patients' safety is well-thought-of.