Speed to market is a critical component of any drug development strategy – not only from a commercial standpoint, but also for patients awaiting better treatment options. Throughout the drug development process there are many factors influencing speed to market but none more visible and critical than an expedited regulatory review.

The debate around how regulators can facilitate this process on both sides of the Atlantic has been top of mind for decades. During the early 1980s public outrage focused the FDA on faster reviews of HIV/AIDS treatments. In 2012, the FDA Safety and Innovation Act which introduced Breakthrough Therapy Designation, was followed by a final guidance in 2014 describing requirements for the four main expedited pathways, Fast Track(1), Breakthrough Therapy Designation (2), Accelerated Approval(3) and Priority Review(4). In 2016, the Regenerative Medicines Advanced Therapy Designation, designed for expedited reviews of certain biologics, came about because of the 21st Century Cures Act. Recently, another expedited review process for antibacterial and antifungal agents, the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) has been established.

Each of these pathways have specific requirements that must be addressed to receive the designation requested. Each also offers various benefits such as more frequent FDA interactions, possibility for rolling submissions, engagement of senior FDA management and/or the possibility of shortened review times. Not surprisingly, not all applications are successful.

Data from the drug division of FDA, CDER, show that since 2012 when Breakthrough Therapy Designation became available through the end of 2019 there were 792 requests for this designation with 317 requests granted; the remainder being denied or withdrawn (5). These data demonstrate that while the first step towards a successful expedited review is making sense of which of these many options is best for a product, it is the development of the strategy and application itself that remains the critical success factor.
At NDA we support companies, in all therapeutic areas across the full range of expedited pathways in both the EU and US.

We will be discussing this in more detail in our upcoming webinar, where we will be ready to answer any questions that you may have.



1. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

2. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy

3. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval

4. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review

5. https://www.fda.gov/drugs/ind-activity/breakthrough-therapy-designation-requests

The Author

Frank Casty, MD


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