EAPs are regulatory approved programs that allow sponsors to make their pre-approval products available to patients outside the clinical trial. EAPs offer a variety of benefits to companies.
- These regulatory approved programs provide companies with additional opportunities to assess a drug prior to the full launch
- Companies can generate additional safety and real world data that helps in understanding how the drug will be used in clinical practice
- Sponsors can manage risk in the pre-launch setting through appropriate adverse event capture and screening patients to ensure the correct cohorts are selected to take the medicine
- The programs give physicians experience with using the new medicine, creating advocates for the drug prior to its launch
- EAPs help a company build relationships with both doctors and patients
If you are a Sponsor with a product in development and you require the deployment of an EAP, or you wish to discuss distribution of your drugs to manage product requests from patients/physicians, please contact us at: