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U.S. Department of Health and Human Services

Science & Research

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Collaborative Opportunities

FDA Technology Transfer Program
Government * Industry * Academia

CRADAs | Inventions and Patents | Licensing

 

FDA Technology Transfer Program (FDATT) provides current policies and procedures to assist the FDA community and potential collaborators to develop and transfer federal technology to the commercial marketplace.

 

The Federal Technology Transfer Act of 1986 (FTTA) which amended the Stevenson-Wydler Technology Innovation Act of 1980; Executive Order 12591 of April 10, 1987; the National Technology Transfer Advancement Act of 1995, and other Public Health Service (PHS) policies

encourage greater interactions and collaborations among Federal laboratories, state and local governments, universities, and the private sector.

FTTA created the mechanism for such collaborations, the Cooperative Research and Development Agreement (CRADA), and provided incentives for

  • Federal scientists (royalties from licensed inventions)
  • Federal laboratories (additional research resources and expertise), and
  • CRADA partners(exclusive licenses for patented inventions).

The FTTA makes it the responsibility of each technical employee, as well as the Agency's management structure, to develop opportunities to transfer technology. The Agency continues to strongly support collaborative research and development under CRADAs that are within FDA's mission and that may result in patents and licenses which promote public health.

 

FDA has internal procedures for establishing CRADAs; filing Invention Reports; and, through a formal agreement with NIH's Office of Technology Transfer, licensing patented inventions and biological materials. We also have a Fair Access and Conflict of Interest policy to safeguard the Agency and the scientist while fostering collaborative efforts. All these topics are addressed in the selections which follow.

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