National Institutes of Health

Description

The National Institutes of Health (NIH), participating NIH Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (UT2) applications to support small business research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE.

Who can apply

• Small businesses

Contact

NIH OER Webmaster<br/>FBOWebmaster@OD.NIH.GOV<br/>
FBOWebmaster@OD.NIH.GOV