In this section your goal is to provide the FDA with a summary of any clinical data that has been accrued (only in the case that there has been prior use in patients). Additionally, you can also use this section to disclose key findings from prior and/or ongoing human trials and information regarding upcoming/planned ones as well. Long-term follow-up is another important piece of data to provide to the FDA – you will need to provide the FDA with any data that may suggest long-term performance of the product post-administration. Consider following the decision tree below to determine the best approach, based on your development plan, you should use for tackling this section.
If you don’t have natural history studies or prior clinical data for your product (which is typical for BGTC candidates), then please skip directly to the Planned/upcoming clinical studies section.
Clinical Data Summary > Do you have clinical data for your product?
YES - Follow Route A! - Provide your product’s clinical data summaries.
NO - Follow Route B!- Provide clinical efficacy evidence for analogous product.