# BGTC Regulatory Playbook

> Knowledge base documentation for BGTC Regulatory Playbook.

## v1

- [Introduction to the BGTC Regulatory Playbook](https://bgtcplaybook.document360.io/docs/introduction-to-the-bgtc-regulatory-playbook.md)
- [BGTC vision and philosophy](https://bgtcplaybook.document360.io/docs/bgtc-vision-and-philosophy.md)
- [Streamlined approaches to bespoke gene therapy development](https://bgtcplaybook.document360.io/docs/streamlined-approaches-to-bespoke-gene-therapy-development-1.md)
- [Minimum pre-clinical testing](https://bgtcplaybook.document360.io/docs/13-minimum-pre-clinical-testing.md)
- [How to use this playbook](https://bgtcplaybook.document360.io/docs/how-to-use-this-playbook.md)
- [Platform-based approach for AAV gene therapies](https://bgtcplaybook.document360.io/docs/platform-based-approach-for-aav-gene-therapies.md)
- [Formal FDA meetings](https://bgtcplaybook.document360.io/docs/fda-meetings.md)
- [Formal FDA meeting types](https://bgtcplaybook.document360.io/docs/formal-fda-meeting-types.md)
- [Summary of the different meeting management procedural goals](https://bgtcplaybook.document360.io/docs/summary-of-the-different-meeting-management-procedural-goals.md)
- [What are the different formal FDA meeting formats?](https://bgtcplaybook.document360.io/docs/what-are-the-different-formal-fda-meeting-formats.md)
- [How to request a formal FDA meeting?](https://bgtcplaybook.document360.io/docs/how-to-request-a-formal-fda-meeting.md)
- [How to prepare the meeting package?](https://bgtcplaybook.document360.io/docs/how-to-prepare-the-meeting-package.md)
- [How the FDA assesses and responds to meeting requests](https://bgtcplaybook.document360.io/docs/how-the-fda-assesses-and-responds-to-meeting-requests.md)
- [Steps to take while conducting a meeting](https://bgtcplaybook.document360.io/docs/steps-to-take-while-conducting-a-meeting.md)
- [Meeting minutes](https://bgtcplaybook.document360.io/docs/meeting-minutes.md)
- [Formal FDA meetings that this playbook focuses on](https://bgtcplaybook.document360.io/docs/formal-fda-meetings-that-his-playbook-focuses-on.md)
- [INTERACT meeting](https://bgtcplaybook.document360.io/docs/interact-meeting.md)
- [What is an INTERACT meeting?](https://bgtcplaybook.document360.io/docs/what-is-an-interact-meeting.md)
- [Should I consider an INTERACT meeting?](https://bgtcplaybook.document360.io/docs/should-i-consider-an-interact-meeting.md)
- [Am I ready for an INTERACT meeting?](https://bgtcplaybook.document360.io/docs/am-i-ready-for-an-interact-meeting.md)
- [Things to be aware of before continuing](https://bgtcplaybook.document360.io/docs/things-to-be-aware-of-before-continuing.md)
- [Meeting preparation and conduct](https://bgtcplaybook.document360.io/docs/interact-meeting-preparation.md)
- [Meeting request](https://bgtcplaybook.document360.io/docs/interact-meeting-request.md)
- [Meeting information package preparation](https://bgtcplaybook.document360.io/docs/meeting-information-package-preparation-1.md)
- [Preparation for the INTERACT meeting](https://bgtcplaybook.document360.io/docs/preparation-for-the-interact-meeting.md)
- [Post-meeting follow-up](https://bgtcplaybook.document360.io/docs/post-meeting-follow-up.md)
- [Pre-IND meeting](https://bgtcplaybook.document360.io/docs/pre-ind-meeting.md)
- [What is a Pre-IND meeting?](https://bgtcplaybook.document360.io/docs/what-is-a-pre-ind-meeting.md)
- [Should I consider a Pre-IND meeting?](https://bgtcplaybook.document360.io/docs/should-i-consider-a-pre-ind-meeting.md)
- [Am I ready for a Pre-IND meeting?](https://bgtcplaybook.document360.io/docs/am-i-ready-for-a-pre-ind-meeting.md)
- [Things to be aware of before continuing](https://bgtcplaybook.document360.io/docs/things-to-be-aware-of-before-continuing-1.md)
- [Pre-IND meeting request](https://bgtcplaybook.document360.io/docs/pre-ind-meeting-request-1.md)
- [Meeting information package preparation](https://bgtcplaybook.document360.io/docs/meeting-information-package-preparation.md)
- [Introduction, purpose, and objective of the meeting](https://bgtcplaybook.document360.io/docs/introduction-purpose-and-objective-of-the-meeting.md)
- [Proposed agenda of the meeting and attendees](https://bgtcplaybook.document360.io/docs/proposed-agenda-of-the-meeting-and-attendees.md)
- [Product background](https://bgtcplaybook.document360.io/docs/product-background.md)
- [Questions for the agency grouped by discipline](https://bgtcplaybook.document360.io/docs/questions-for-the-agency-grouped-by-discipline.md)
- [Regulatory background](https://bgtcplaybook.document360.io/docs/regulatory-background.md)
- [Chemistry, Manufacturing, and Controls information summary](https://bgtcplaybook.document360.io/docs/chemistry-manufacturing-and-controls-information-summary.md)
- [Pre-clinical data summaries](https://bgtcplaybook.document360.io/docs/pre-clinical-data-summaries.md)
- [Clinical data summaries](https://bgtcplaybook.document360.io/docs/clinical-data-summaries-1.md)
- [Route A](https://bgtcplaybook.document360.io/docs/route-a.md)
- [Route B](https://bgtcplaybook.document360.io/docs/route-b.md)
- [Preparation for the Pre-IND Meeting](https://bgtcplaybook.document360.io/docs/preparation-for-the-pre-ind-meeting.md)
- [Post-meeting follow-up](https://bgtcplaybook.document360.io/docs/post-meeting-follow-up-1.md)
- [Expedited pathways & designations](https://bgtcplaybook.document360.io/docs/expedited-pathways-and-designations.md)
- [Orphan Drug Designation](https://bgtcplaybook.document360.io/docs/orphan-drug-designation-1.md)
- [Rare Pediatric Disease](https://bgtcplaybook.document360.io/docs/rare-pediatric-disease-1.md)
- [Expedited programs](https://bgtcplaybook.document360.io/docs/expedited-programs-1.md)
- [Fast Track](https://bgtcplaybook.document360.io/docs/fast-track-1.md)
- [Breakthrough Therapy](https://bgtcplaybook.document360.io/docs/breakthrough-therapy-1.md)
- [Regenerative Medicine Advanced Therapy (RMAT)](https://bgtcplaybook.document360.io/docs/regenerative-medicine-advanced-therapy-rmat-1.md)
- [Accelerated Approval](https://bgtcplaybook.document360.io/docs/accelerated-approval-1.md)
- [Priority review](https://bgtcplaybook.document360.io/docs/priority-review-1.md)
- [Case studies](https://bgtcplaybook.document360.io/docs/case-studies-1.md)
- [IND preparation and submission](https://bgtcplaybook.document360.io/docs/ind-submission.md)
- [Module 1: Admin information](https://bgtcplaybook.document360.io/docs/module-1-admin-information-1.md)
- [Module 2: Summary documents](https://bgtcplaybook.document360.io/docs/module-2-summary-documents.md): IND Submission Summary Documents
- [Module 2.3: Quality overall summary](https://bgtcplaybook.document360.io/docs/module-23-quality-overall-summary.md)
- [Module 2.4: Non-clinical overview](https://bgtcplaybook.document360.io/docs/module-24-non-clinical-overview.md)
- [Module 2.5: Clinical overview – NOT APPLICABLE unless drug has clinical data](https://bgtcplaybook.document360.io/docs/module-25-clinical-overview-not-applicable-unless-drug-has-clinical-data.md)
- [Module 2.6: Non-clinical written and tabulated summaries](https://bgtcplaybook.document360.io/docs/module-26-non-clinical-written-and-tabulated-summaries.md)
- [Module 2.7: Clinical summary – NOT APPLICABLE unless drug has clinical data](https://bgtcplaybook.document360.io/docs/module-27-clinical-summary-not-applicable-unless-drug-has-clinical-data.md)
- [Module 3: Quality](https://bgtcplaybook.document360.io/docs/module-3-quality-1.md)
- [Module 4: Non-clinical data](https://bgtcplaybook.document360.io/docs/module-4-non-clinical-data-1.md)
- [Module 5: Clinical study reports](https://bgtcplaybook.document360.io/docs/module-5-clinical-study-reports-1.md)
- [IND maintenance](https://bgtcplaybook.document360.io/docs/ind-maintenance-2.md)
- [Clinical trial planning, design and execution: Considerations and best practices](https://bgtcplaybook.document360.io/docs/considerations-and-best-practices-for-clinical-trial-planning-design-and-execution.md)
- [Clinical trial design](https://bgtcplaybook.document360.io/docs/clinical-trial-design.md)
- [Early-phase trial objectives](https://bgtcplaybook.document360.io/docs/early-phase-trial-objectives.md)
- [Choosing a study population](https://bgtcplaybook.document360.io/docs/choosing-a-study-population.md)
- [Control group and blinding](https://bgtcplaybook.document360.io/docs/control-group-and-blinding.md)
- [Dose and regimen](https://bgtcplaybook.document360.io/docs/dose-and-regimen.md)
- [Treatment plan](https://bgtcplaybook.document360.io/docs/treatment-plan.md)
- [Patient engagement and patient-centricity: Considerations and best practices](https://bgtcplaybook.document360.io/docs/considerations-and-best-practices-for-patient-engagement-and-patient-centricity.md)
- [Challenges – particularly for rare disease](https://bgtcplaybook.document360.io/docs/challenges-particularly-for-rare-disease.md)
- [Considerations and best practices](https://bgtcplaybook.document360.io/docs/considerations-and-best-practices.md)
- [Study site management](https://bgtcplaybook.document360.io/docs/study-site-management.md)
- [Long-term follow-up](https://bgtcplaybook.document360.io/docs/long-term-follow-up.md)
- [Resources - Regulatory templates](https://bgtcplaybook.document360.io/docs/resources-regulatory-templates.md)
- [Resources - Official FDA Submissions and Responses](https://bgtcplaybook.document360.io/docs/resources-official-fda-submissions-and-responses.md)
- [References](https://bgtcplaybook.document360.io/docs/references.md)
- [REF: Intro to BGTC Playbook](https://bgtcplaybook.document360.io/docs/ref-intro-to-bgtc-playbook.md)
- [REF: Platform-based approach for AAV Gene Therapies](https://bgtcplaybook.document360.io/docs/ref-platform-based-approach-for-aav-gene-therapies.md)
- [REF: Formal FDA Meeting Types](https://bgtcplaybook.document360.io/docs/ref-formal-fda-meeting-types.md)
- [REF: INTERACT Meeting](https://bgtcplaybook.document360.io/docs/ref-interact-meeting.md)
- [REF: Pre-IND Meeting](https://bgtcplaybook.document360.io/docs/ref-pre-ind-meeting.md)
- [REF: Expedited Pathways & Designations](https://bgtcplaybook.document360.io/docs/ref-expedited-pathways.md)
- [REF: IND Submission](https://bgtcplaybook.document360.io/docs/ref-ind-submission.md)
- [REF: Clinical Trial Planning, Design, Execution](https://bgtcplaybook.document360.io/docs/ref-clinical-trial-planning-design-execution.md)
- [REF: IND Maintenance](https://bgtcplaybook.document360.io/docs/ref-ind-maintenance.md)
- [REF: Patient Engagement and Patient Centricity](https://bgtcplaybook.document360.io/docs/ref-patient-engagement-and-patient-centricity.md)
- [REF: Study Site Management](https://bgtcplaybook.document360.io/docs/ref-study-site-management.md)
- [REF: Long-Term Follow Up](https://bgtcplaybook.document360.io/docs/ref-long-term-follow-up.md)