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Office of New Drugs Regulatory Science Research

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The Office of New Drugs Research Program (OND-RP) was created in 2019 to foster regulatory science research (RSR). OND-led RSR projects are designed to address knowledge gaps identified during regulatory review of investigational or new drug applications. 

OND conducts RSR to reduce uncertainty around regulatory decision making. External stakeholders benefit from RSR as project outcomes provide information needed to streamline regulatory review. An example is a retrospective study of external pediatric patient records to define the natural history of a life-threatening infection that does not have an FDA-approved treatment available. Understanding the effect of supportive clinical care on this patient population helps OND and their stakeholders develop consensus on study design aspects such as efficacy endpoints. Addressing this knowledge gap also benefits public health as it helps to establish a clear regulatory pathway to approval which stimulates new drug development.

OND participates in extramural and intramural RSR using the mechanisms described below.

Extramural Research 

OND uses FDA’s Broad Agency Announcement (BAA) program to conduct collaborative extramural RSR. The BAA program is a specialized contract mechanism designed to solicit innovative RSR study designs from external subject matter experts. Every year, FDA’s BAA program posts a solicitation document on an external website to alert external partners of the knowledge gaps FDA needs to address. Project ideas are solicited from industry, academia, and other government agencies. RSR projects with high potential to facilitate new drug approvals may be selected for funding from OND.

OND is currently accepting RSR projects from the following sections in the BAA solicitation document:

  • Section III. Invigorate public health preparedness and response of the FDA, patients, and consumers, Part B: Antimicrobial Resistance

Another mechanism OND uses to initiate collaborative RSR with external SMEs is FDA’s Centers for Excellence in Regulatory Science and Innovation (CERSI) program. The CERSI program consists of a group of academic institutions that applied to and were selected through a Funding Opportunity Announcement (FOA) posted by FDA’s Office of the Chief Scientist.  The cooperative agreement that supports this program is re-established every five years. RSR project ideas can either be solicited from the CERSIs or provided to them from OND staff. Study designs are co-developed and may be funded by OND depending on availability of resources.

OND conducts collaborative research with various federal, state, or local government agencies using tools such as Inter-Agency Agreements (IAAs) and Memorandum of Understanding (MOUs).

This link provides Examples of MOUs established with academic, domestic, and other partners.

OND staff participate in public-private partnerships (PPPs) and consortia to provide FDA’s perspective on multi-stakeholder driven scientific research. External partners who would like to request OND staff participation in a consortium or Public Private Partnership (PPP) should reach out to OTS-PPPCoordinator@fda.hhs.gov.

Here are some examples of existing PPPs and consortia with CDER staff participants.

Intramural Research 

The Oak Ridge Institute for Science and Education (ORISE) fellowship program provides OND staff with the opportunity to design and conduct mentor-led RSR projects. Fellowship opportunities are available to currently enrolled students or recent (5 years or less) graduates. Many OND ORISE alumni pursue Federal careers, which makes this program a powerful workforce development tool. Candidates interested in OND ORISE fellowship opportunities can search and apply to open announcements. OND ORISE fellows receive competitive stipends and access to health insurance as part of this program.

Examples of OND ORISE fellowship outcomes:

Another opportunity OND uses to conduct intramural research is the Translational Science Interagency Fellowship (TSIF). This collaborative regulatory science training opportunity is funded by the National Institutes of Health (NIH), National Center for Translational Sciences (NCATS). The primary objective of the NCATS-FDA TSIF program is to train post-doctoral fellows in both regulatory review and translational science. TSIF fellows spend half of their time at FDA and half at NIH. OND mentors co-develop projects with members of NCATS staff.  List of TSIF projects and mentors

Targeted Funding Opportunities Open to External Partners

OND’s Drug Development Tool (DDT) grant program is a targeted investment designed to support research to continue the development of DDTs with an accepted Letter of Intent (LOI) in one of the following DDT qualification programs: Animal Models, Biomarkers, Clinical Outcomes Assessments, or the Innovative Science and Technology Approaches for New Drugs (iSTAND) pilot program).

The OND Antimicrobial Regulatory Science Research program is designed to address knowledge gaps that, when addressed, will facilitate development of new antibacterial drugs.  This link provides information on open funding opportunities and reports on previously funded projects.

Example of a project funded by this program:

Exploiting Real-World Data to Optimize the Use of Antibiotics

Other OND RSR Resources

Other CDER RSR Resources

Contact us

This mailbox (ONDResearch@fda.hhs.gov) is intended for external partners to submit suggestions for regulatory science knowledge gaps in new drug development.

Feedback will be discussed internally and may be used to develop public meetings and workshops or could result in research projects.

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