REAL-WORLD EVIDENCE

What is the Big Deal with the FDA’s new RWE Program?

The FDA’s recent framework for the use of Real World Evidence allows the collection of data in the "real world" to be used in FDA submissions. However, this framework fails to address how this data can impact your research and approvals, leaving many drug and device developers unsure how to proceed.

In our new E-Book, we analyze the most important pieces of the framework and give valuable insight for how to use RWD effectively. Download your free copy today.

Please complete the form to access the 17 Page E-Book (PDF File)

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Why use RWD and RWE?

In taking advantage of the FDA’s new RWE program, researchers are able to evaluate the unique aspects of post-market medical products as they are used in the real world. This provides opportunities to use RWE to support the approval of new indications for drugs and biological products already approved or to support and satisfy post-approval study requirements, such as monitoring safety and efficacy. It can also provide evidence for optimal dosages, uses, and applications in real-world settings.

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What You Will Learn

  • Who has already been using RWD
    • What real world data can do for your FDA applications
    • Where can real world data be found
      • When is it appropriate to use RWD?
    • Why real world data is so powerful
    • How to use RWD and RWE in practice

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