FDA Special Designations and Programs for Pipeline Drugs: How They Impact Drug Development Overview

Part 1 of 2: Special Designation Overview
This is the first part of a two-part series from Two Labs Drug Pipeline Manager, Ryan Chandanais

The FDA has several special designations or programs to facilitate the development of drugs treating
conditions with an unmet medical need. Certain designations can reduce FDA timelines for reviewing a New Drug Application (NDA) or Biologics License Application (BLA). Others can reduce the time spent in clinical trials prior to FDA submission. This allows manufacturers to have a larger window of time between drug launch and eventual loss of exclusivity when generic or biosimilars reduce their sales. Some designations provide other incentives for drug developers. Key designations and programs include:

Priority Review

Accelerated Approval

Fast Track


Regenerative Advanced Medicine Therapy (RMAT)


Priority Review Vouchers

Qualified Infectious Disease Product (QIDP)

Real-Time Oncology Review

Drugs can earn multiple special designations. In fact, 65% of novel new drugs approved by the Center for Drug Evaluation and Research (CDER) had ≥1 special designation or program awarded by the FDA. And while special designations bring certain benefits to their manufacturer, they don’t guarantee FDA approval.

The FDA must always strike a balance between approving new drugs in a timely fashion so they can be used by patients in need without unnecessary waiting and requiring enough supporting evidence to assure safety and efficacy of new drugs, which is time consuming. The special programs and designations we’ve discussed here are mechanisms for expediting approval and/or incentivizing new drug development for unmet clinical needs. The impact of these programs/designations are worth understanding for those who are interested in drug development.

Want to dig into each special designation?

Read Ryan’s follow up blog to learn more about what each of these designations/programs does, how they can impact the timing of an FDA approval, and what they can do for pipeline drugs and manufacturers you’re interested in.

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