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Fast-tracking Medicines to Patients in Need: Navigating the FDA’s Expedited Tracks to Accelerate Your Drug Discovery and Development.

Set up your drug discovery breakthroughs for fast-track success.

Even the most promising candidates in any drug discovery program can take 7-10 years and billions of dollars to ultimately achieve FDA approval and reach the market. This may make you wonder whether your drug is eligible for an expedited track. The FDA started the expedited drug program to address the difficulty of getting drugs for rare diseases and serious conditions lacking therapies to market. In this whitepaper, we provide guidance on the four key expedited programs and how working with InVivo Biosystems can position you to take advantage of them.

In this whitepaper, you will learn:

  • What Expedited track is best for my drug candidate?
  • What preliminary data do I need to apply for each track? 
  • How will partnering with InVivo Biosystems help prepare my drug for application?
  • What are the benefits of pursuing one expedited track or another

Talk with our experts

Learn how InVivo Biosystems can help you acquire the data to prime your drug discovery program for the FDA’s Expedited Tracks.

About The Author

Alexandra Narin

Alexandra is the Marketing Content Manager and Grant Writer for InVivo Biosystems. She graduated from the University of St Andrews in 2020 where she earned a Joint MA Honours Degree in English & Psychology/Neuroscience with BPS [British Psychology Society] Accreditation. She has worked as a research assistant, examining the LEC's (lateral entorhinal cortex) involvement in spatial memory and integrating long term multimodal item-context associations, and completed her dissertation on how the number and kinds of sensory cues affect memory persistence across timescales. Her hobbies include running, boxing, and reading.

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