1 min read

Shortening Development and Approval Timelines for Novel Medicinal Products

The FDA and EMA offer expedited regulatory approval pathways to accelerate time-to-market for novel therapies intended to treat serious conditions and unmet medical needs. There are twelve special designations, many of which reduce clinical development and approval timelines. However, these are not always granted.

In this infographic, Veristat regulatory experts highlight the benefits of, qualifying criteriaDownload the Infographic for, and timing and procedures for twelve expedited programs and designations. Companies must build a strategic regulatory plan and leverage the right pathways to ensure a seamless regulatory strategy and submission plan for both U.S. and global registrations. Overall, these expedited regulatory pathways can save time and reduce the cost of bringing therapies to market—and to patients—sooner.

Download the infographic to learn more about the benefits of these key special designations:

  • Orphan Drug Designation
  • Breakthrough Therapy (BT)
  • PRIority MEdicines (PRIME)
  • Fast Track (FT)
  • Qualified Infectious Disease Product Designation (QIDP)
  • Regenerative Medicine Advanced Therapy (RMAT)
  • Priority Review (PR)
  • Accelerated Approval
  • Emergency Use Authorization (EUA)
  • Accelerated Assessment (AA)
  • Conditional Marketing Authorization (CMA)
  • Real Time Oncology Review (RTOR)



Screen Shot 2022-11-05 at 12.20.20 PM


Meet Veristat. Learn More.


1 min read

TOPRA Symposium 2024

Meet Veristat at the TOPRA Symposium 2024 from 30 September - 2 October in Rotterdam, the Netherlands 

The Veristat...

1 min read

World Orphan Drug Congress EUROPE  2024

Veristat is excited to announce its participation in this year's World Orphan Drug Congress Europe, held in Barcelona,...