---
title: "REF: Expedited Pathways & Designations"
slug: "ref-expedited-pathways"
updated: 2026-02-11T21:33:05Z
published: 2026-02-11T21:33:05Z
canonical: "bgtcplaybook.document360.io/ref-expedited-pathways"
---

> ## Documentation Index
> Fetch the complete documentation index at: https://bgtcplaybook.document360.io/llms.txt
> Use this file to discover all available pages before exploring further.

# REF: Expedited Pathways & Designations

1. Accelerated Approval | FDA. (2023, February 24). Retrieved from Food and Drug Administration: [https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval](https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval)
2. Breakthrough Therapy | FDA. (2018, April 01). Retrieved from Food and Drug Administration: [https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy](https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy)
3. Designating an Orphan Product: Drugs and Biological Products | FDA. (2022, 08 07). Retrieved from Food and Drug Administration: [https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products](https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products)
4. Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Guidance for Industry (fda.gov). (2019, February). Retrieved from Food and Drug Administration: [https://www.fda.gov/media/120267/download](https://www.fda.gov/media/120267/download)
5. Expedited Programs for Serious Conditions – Drugs and Biologics. (2020, 06 25). Retrieved from Food and Drug Administration: [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics)
6. Fast Track | FDA. (2018, April 01). Retrieved from Food and Drug Administration: [https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track](https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track)
7. FDA Designations For Rare Disease Products, Part 3: Rare Pediatric Disease Designation | Premier Consulting. (2021, 03 25). Retrieved from Premier Consulting: [https://premierconsulting.com/resources/blog/fda-designations-for-rare-disease-products-part-3-rare-pediatric-disease-designation/#:~:text=A%20rare%20pediatric%20disease%20is,infants%2C%20children%2C%20and%20adolescents](https://premierconsulting.com/resources/blog/fda-designations-for-rare-disease-products-part-3-rare-pediatric-disease-designation/#:~:text=A%20rare%20pediatric%20disease%20is,infants%2C%20children%2C%20and%20adolescents)
8. Orphan Drug Designation Request Form | FDA. (2021, July 09). Retrieved from Food and Drug Administration: [https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/orphan-drug-designation-request-form](https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/orphan-drug-designation-request-form)
9. Priority Review | FDA. (2018, April 01). Retrieved from Food and Drug Administration: [](https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-revie)[https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review](https://www.fda.gov/patients/rare-diseases-fda)
10. Rare Diseases at FDA. (2022, 12 13). Retrieved from Food and Drug Administration: [https://www.fda.gov/patients/rare-diseases-fda](http://etrieved from Food and Drug Administration: https://www.fda.gov/patients/rare-diseases-fda Rare Pediatric Disease (RPD) Designa)
11. Rare Pediatric Disease (RPD) Designation and Voucher Programs | FDA. (2023, 06 02). Retrieved from Food and Drug Administration: [https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-rpd-designation-and-voucher-programs](https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-rpd-designation-and-voucher-programs)
12. Rare Pediatric Disease Priority Review Vouchers (fda.gov). (2019, 07). Retrieved from Food and Drug Administration.
13. Regenerative Medicine Advanced Therapy Designation | FDA. (2023, April 19). Retrieved from Food and Drug Administration: [https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation](https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation)
14. Successfully Navigating Food and Drug Administration Orphan Drug and Rare Pediatric Disease Designations for AAV9-hPCCA Gene Therapy: The National Institutes of Health Platform Vector Gene Therapy Experience - PMC (nih.gov). (2023, 03). Retrieved from PubMed: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10031144/](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10031144/)