ACC Submits Principles for Regulatory Burden Reduction to FDA

The ACC submitted a Dec. 7 comment letter to the U.S. Food and Drug Administration (FDA) in response to the Agency's initiative to reduce regulatory burden through a review of existing regulations and information collection requirements. In the comments, the College submitted a set of principles intended to serve as a guide to reduce unnecessary burdens. Among the included principles are calls to:

  • Ensure regulatory decisions are patient-centered and based on scientific merit

  • Balance industry flexibility with safety and effectiveness

  • Allow for necessary therapeutic innovation

  • Collaborate with other federal agencies and professional medical societies

  • Ensure protection of the public health

The ACC supports the Agency's efforts to help reduce administrative and regulatory burdens that affect patients' timely access to new therapies and will continue to engage with the FDA throughout the process. Access the full list of principles and read the letter in its entirety here.

Keywords: ACC Advocacy

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