White Paper

Accelerating Regulatory Product Development And Approval For Drugs And Biologics In The U.S.

Source: Rho

By David Shoemaker, Senior Vice President Research and Development, Genna L A Kingon, PhD, RAC, Research Scientist, and Kathleen Candando, Ph.D., Research Scientist, Kevin Barber, MS, Ph.D., RAC, PMP, Vice President, Regulatory Strategy and Submissions

Approval Pills

The Food and Drug Administration (FDA) has created five mechanisms to presumably speed the approval of drugs and biologics that effectively treat serious diseases, especially those that are the first of their kind or those that provide increased benefit over existing treatments. Accelerated Approval (AA), Breakthrough Therapy Designation (BTD), Regenerative Medicine Advanced Therapy (RMAT) Designation, Fast Track Designation (FTD), and Priority Review (PR) – their names imply speed of the highest order, and it’s tempting to assume that acquiring any of these designations will speed your product’s approval and save you millions of dollars. That’s certainly possible, but just like anything that sounds too good to be true, it’s worth taking the time to understand the requirements and potential benefits of each, so you can make an informed decision about what’s possible or what’s best for your product development program.

An overview of the five types of FDA programs is shown below in Table 1 and is reviewed in the Guidance published in 2014 (Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics; expiration date 05/31/2020) and in a second Guidance published in 2019 (Guidance for Industry: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions). The overlap in benefit and use in development or application review is obvious. However, further analysis is provided below as to how to appropriately use these five programs to maximize speed of approval depending on the product type.

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