OpportunityTitle: Manufacturing Sector Research Initiative
AdditionalInformationOnEligibility: National Institute for Pharmaceutical Technology and Education Initiative (NIPTE), a Nonprofit Other Than Institution of Higher Education, described in section 501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3), which is exempt from tax under section 501(a) of that code. NIPTE is the only consortium of universities of its kind. The organization consists of many of the most highly qualified pharmaceutical manufacturing experts in academia. Research conducted by NIPTE Faculty is collaborative by design to provide for coordinated publication of the cutting edge research results. An eligible organization that wishes to enter into a Critical Path Public-Private Partnership with FDA must provide an assurance that the entity will not accept funding for a Critical Path Public-Private Partnership Project from any organization that manufactures or distributes products regulated by FDA unless the entity provides assurance in its agreement with FDA that the results of the Critical Path Public Partnership project will not be influenced by any source of funding. The entities eligible to enter into partnerships with FDA under this cooperative agreement are governed by section 566 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-5).This cooperative agreement will provide continued support for established and previously funded collaborations on behalf of FDA priorities.
Description: The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a cooperative agreement with the National Institute for Pharmaceutical Technology and Education Initiative (NIPTE). The Agency&apos;s Critical Path Manufacturing Sector Initiative has focused attention on the continuing need for this kind of research in a way that can improve reliability of pharmaceutical product manufacturing and quality across the entire industry. This shared knowledge will increase the likelihood of successfully manufacturing products that have been identified in the clinical development community. The goal of this agreement is to improve the overall manufacturing and quality and the knowledge base
GrantorContactEmailDescription: Work
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592