NIH Intramural Access Planning Policy Set to Take Effect, Additional Guidance Available 

NIH’s Intramural Research Program (IRP) Access Planning Policy goes into effect tomorrow, October 1, 2025. This policy seeks to improve access to medical products developed from NIH-owned inventions. Starting October 1, 2025, organizations applying to NIH for certain commercial patent licenses will be required to provide the agency with an access plan, describing the steps they will take to promote patient access to any new drug, biologic, or medical device that results from the licensed invention.

Additional information about the policy, guidance, and resources can be found through the NIH Office of Technology Transfer website here: https://www.techtransfer.nih.gov/policy/access-policy. NIH will continue to work with stakeholders and communities to support effective implementation of this policy and to promote the best health outcomes for the American public.

Questions may be sent to the NIH Office of Technology Transfer at [email protected].

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NIH and its Partners to Co-Host Regional Listening Session on Efforts to Modernize and Strengthen Biosafety Oversight   

On September 30, 2025, from 2:00 – 4:00 PM ET, NIH and the New England Biological Safety Association, the Mid-Atlantic Biological Safety Association, the Chesapeake Area Biological Safety Association, and the Northeast Biological Safety Association will be co-hosting a virtual listening session to obtain input from stakeholders on NIH’s recently announced initiative to modernize and strengthen biosafety oversight.

The meeting is free and open to the public but pre-registration is required. Priority registration for this listening session will be given to participants located in Region 1 of NIH’s stakeholder map. More information about the goals of the listening session, as well as a draft agenda, webcast information, and details on how to participate can be found on the meeting page of the OSP Website. 

For additional background on NIH’s biosafety initiative, click here.

Questions may be sent to [email protected].

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Upcoming Meeting of the Novel and Exceptional Technology and Research Advisory Committee   

On September 29, 2025, from 1-3 PM ET, NIH will be hosting a virtual meeting of the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).  At this meeting, the committee will discuss the draft report of the Engaging the Public as Partners in Clinical Research (ENGAGE) Working Group.

A draft agenda, meeting materials, and webcast information can be found on the meeting page of the OSP Website.

Questions may be sent to [email protected].

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NIH Launches Comprehensive Effort to Modernize Biosafety Framework    

Today, NIH announced a new effort to modernize and strengthen biosafety policies, practices, and oversight. This forward-looking effort aims to ensure that NIH’s biosafety framework keeps pace with evolving risks posed by rapid advances in science and technology. 

NIH is committed to building a 21st century biosafety system that reflects the realities of today’s scientific landscape. As part of this effort, NIH will be seeking input from across its stakeholder community, including researchers, biosafety professionals, research institutions, policymakers, industry leaders, and members of the public.  

To learn more about this initiative and how you can contribute to shaping the future of NIH’s biosafety framework, please see the full statement from NIH Director, Dr. Jay Bhattacharya.  Additional information can also be found here on the OSP website.

Questions may be sent to [email protected].

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