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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 criteria
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)
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