U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Science & Research
  3. FDA Technology Transfer Program
  4. Licensing and Collaboration Opportunities
  5. The FDA Licensing Process
  1. Licensing and Collaboration Opportunities

The FDA Licensing Process

The Licensing Process at FDA consists of the following steps:

 The FDA Licensing Process

The Licensing Process at FDA 

  • Review the FDA listing of technology abstracts online and select the technology you are interested in licensing
  • Discuss the technology with the contact listed on the abstract to confirm the next steps
  • Submit any necessary Confidential Disclosure agreement for unpublished Patent Application to
    the Agency-level FDA Technology Transfer Program
      
    E-mail to: FDAInventionLicensing@fda.hhs.gov
  • Review the technology with the scientist and the Technology Transfer Specialist
  • Review the various types of licenses available for use online
  • Submit a  License Application to the Agency-level FDA Technology Transfer Program
      
    E-mail to: FDAInventionLicensing@fda.hhs.gov 
  • Include any necessary business development plan with the License Application 

Negotiation of  a Non-Exclusive Agreement

  • Non-exclusive licenses, Biological Materials licenses, commercial evaluation licenses do not require public notice
  • FDA Technology Transfer Program reviews the License application and negotiates a mutually acceptable agreement 

Negotiation of an Exclusive Licenses

  • FDA evaluates the license application using a number of criteria to determine if an exclusive license is warranted (see, 37 CFR §404.7)
  • Exclusive Licenses are subject to a period, generally no more than 30 days, of public notice in the Federal Register
  • Other organizations have this period during which they may object to the exclusive license and/or apply for an exclusive license to the technology
  • After the notice and comment period, FDA will consider any objections and notify you of its decision about the license

Reporting

  • The signed license will list the specific reporting requirement for the license, which theh office will monitor.

 

Back to Top