Expanded access to drug safety information
Examine comparative drug safety approval information and augment it with published data to help make better informed risk management and mitigation decisions.
- Reduce the risk of regulatory cycling with improved preclinical and clinical study design
- Gain insights into prior or emerging concerns on drug safety
- Examine investigational drugs for additional indications
Stay better informed on post-market drug developments through comparative study approaches, and examination of FAERS and post-market data.
- Monitor off-label uses of drugs to identify potential new indications of already approved drugs
- Better anticipate if Phase IV studies will be required
- Optimize clinical and post-market study designs by examining comparative data on select patient subpopulations and clinical endpoints