The 21st Century Cures Act and Real World Evidence: . . .

The 21st Century Cures Act and Real World Evidence: . . .
The 21st Century Cures Act and Real World Evidence: What The Trial Lawyer Needs to Know

The 21st Century Cures Act (Cures Act) was designed to accelerate the discovery, development, and delivery of new medical products. One key feature of the Cures Act is that patients’ perspectives are to be further incorporated in the FDA’s decision-making process. The Cures Act also includes a framework for evaluating the use of real world evidence and data to support the FDA’s regulatory decisions. The Cures Act was widely supported by the pharmaceutical and medical device industry and could bring great benefit to patients and to the advancement of medical products. At the same time, the acceleration in approval of medical products, the use of patients’ perspectives in the approval process, and the use of non-clinical trial data in regulatory decision-making will bring some of plaintiffs’ favorite trial themes to the forefront. Join us for a discussion on what this might mean for trial strategy and how to effectively address these themes at trial.

Webinars are complimentary. Please note that the IADC does NOT apply for CLE Credit for its Webinars. However, attendees are welcome to apply for and/or claim credit as their jurisdictions allow. Please contact your state accrediting agency for state-specific requirements and rules.
When
11/13/2019 12:00 PM - 1:00 PM
Where
UNITED STATES
 

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