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Guiding Principles for Leveraging at FDA

FDA invites the public to comment on these draft Guiding Principles for Leveraging at FDA. We intend to use these principles to guide us as we explore and implement new collaborative ventures with academia, health providers, other government agencies, regulated industry, and, of course, consumers, so your comments are very important to us. You can send us your comments.

By choosing to work with other organizations that share our public health and safety goals, FDA can significantly amplify its public health impact, leverage the intellectual capital of others, and make wise use of its resources. FDA has been quite successful with its past collaborations and the agency intends to expand and build upon this solid foundation in developing new partnerships.

What is leveraging? Leveraging is the creation of relationships and/or formal agreements with others outside the FDA that will ultimately enhance FDA's ability to meet its public health mission. Leveraging is a continuum.

The guiding principles for leveraging at FDA are:

  1. Leveraging can produce greater net benefits, e.g., by sharing talent and material resources and achieving results through synergism.
  2. Successful leveraging provides benefits and incentives for all participants. In addition to FDA this may include consumers, industry, academia, health providers, and other government agencies. In particular, leveraging efforts should increase consumer confidence in regulated products.
  3. Successful leveraging requires
  4. Leveraging must work within established FDA legal authority.
  5. FDA's status as a scientific regulatory agency requires an added dimension of due diligence and management of leveraged relationships by professionals at all levels within the agency.
  6. Leveraging activities should not
  7. Leveraging can be accomplished through a wide variety of collaborative arrangements, both formal and informal. December 13, 1999.

How Will FDA Look in Five Years In Regard to Outside Leveraging?

FDA's Current Vision Supports a Leveraging Commitment

The following components of FDA's Vision Statement support outside leveraging.

FDA is:

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