OpportunityTitle: Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional
AdditionalInformationOnEligibility: Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Description: The goal of this program is to support the advancement of regulatory science to facilitate the implementation and the assessment of continuous manufacturing and similar innovative monitoring and control techniques in the pharmaceutical sector. This will be accomplished by making awards to institutions of higher education and nonprofit organizations for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products (e.g., monoclonal antibodies and therapeutic enzymes). Examples of activities could include the development or modification of a novel manufacturing process (e.g., design, scale-up, and/or commercial scale), control method, and/or testing technology. Awards made under this FOA may be funded in part by appropriations received under the 21st Century Cures Act, section 3016.
GrantorContactEmailDescription: Work Email
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592
CloseDateExplanation: This announcement has multiple deadlines:Current Close Date : May 14,2019 by 11:59 PM Eastern Time.April 6, 2020, by 11:59 PM Eastern Time. April 5, 2021, by 11:59 PM Eastern Time.