FDA Guidance For ABPM: Capture the Data That Matters

In May of 2018, the FDA issued draft guidance advising sponsors on assessing a drug’s effect on blood pressure during a clinical trial. Clarified further in 2019, this guidance is the result of regulators looking for a connection between blood pressure and cardiovascular events during drug therapy.

Patricia Castellano – Senior Director, Product Management, ERT

According to the FDA, ambulatory blood pressure monitoring (ABPM) assessment is the best way to describe blood pressure effects over a period of 24 hours.

To learn more about this FDA guidance, ABPM, and blood pressure monitoring best practices, please join us on July 18.

Key takeaways from this webinar:

  • Understand the FDA Guidance for blood pressure
  • Discuss how to implement ABPM in your trials
  • Uncover best practices and considerations for monitoring blood pressure