The FDA has created four mechanisms to expedite development and approval of drugs and biologics that effectively treat serious diseases: Accelerated Approval, Breakthrough Therapy Designation, Priority Review and Fast Track Designation. Understanding the requirements and benefits of each can inform decisions for your development program.
Accelerated Approval: It can take a long time for products to show actual patient improvement. The AA regulation allows expedited development of products based on a surrogate clinical endpoint that is reasonably likely to predict the clinical benefit.
AA does not change marketing application review time. Instead, it shortens development time prior to approval. If granted, FDA requires a post-marketing commitment to studying established clinical outcomes.
Breakthrough Therapy Designation: Obtaining BTD comes with considerable advantages, notably the commitment from FDA management to champion products through approvals. To avoid wasting FDA resources, the designation requires preliminary data to demonstrate safety and efficacy. Early discussion with the FDA prior to submission of the BTD application is recommended.
Priority Review: PR is a possibility for products “that offer major advances in treatment, or provide a treatment where no adequate therapy exists.” Sponsors must request PR, and the designation is given after the application is filed. The chance of getting PR should be discussed at the pre-BLA/NDA meeting. The FDA’s filing meeting should occur by Day 30—15 days sooner than the standard review—if your application is likely to qualify.
Fast Track Designation: FTD is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. While well-intended, FTD does little to accelerate the approval process by purporting to provide the following: more frequent meetings with the FDA; more frequent written correspondence from the FDA; eligibility for Accelerated Approval; rolling review; and dispute resolution if the drug company is not satisfied with the FDA’s decision.
Written by Guest Writer Dr. David Shoemaker. Shoemaker of CRO Rho has more than 25 years of experience in research and pharmaceutical development. He has served as a program leader or advisor for multidisciplinary program teams and has been involved with products at all development stages. He has managed the regulatory strategy for programs involving multiple therapeutic areas. Dr. Shoemaker has experience in the preparation and filing of regulatory submissions including primary responsibility for four BLAs and three NDAs. He has managed or contributed to more than two dozen NDAs, BLAs and MAAs.
This article was reprinted from Volume 22, Issue 10, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>
