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Plenary Session Presentation: Putting Science First in Rare Disease Studies
Don´t miss Veristat’s plenary presentation at the World Orphan Drug Congress (WODC), Boston, Thursday, April 25th at...
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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:
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Mar 22, 2024 Veristat Events
Don´t miss Veristat’s plenary presentation at the World Orphan Drug Congress (WODC), Boston, Thursday, April 25th at...
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Mar 19, 2024 Veristat Events
Meet Veristat in Basel at the Swiss Biotech Day, 22-23 April 2024
With nearly 30 years of experience in clinical trial...