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FDA expedites drug/biologic development and approval

Thursday, October 15, 2015

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.comSubscribe >>

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