Enhancing Regulatory Science for Advancing Pharmaceutical Quality and Manufacturing (U01) Clinical Trials Optional


Funding Opportunity ID: 323532
Opportunity Number: PAR-20-083
Opportunity Title: Enhancing Regulatory Science for Advancing Pharmaceutical Quality and Manufacturing (U01) Clinical Trials Optional
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Agriculture
Consumer Protection
Food and Nutrition
Category Explanation:
CFDA Number(s): 93.103
Eligible Applicants: County governments
City or township governments
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
For profit organizations other than small businesses
Small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs)o Alaska Native and Native Hawaiian Serving Institutionso 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)For-Profit OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions)
Agency Code: HHS-FDA
Agency Name: Department of Health and Human Services
Food and Drug Administration
Posted Date: Jan 08, 2020
Close Date: Apr 10, 2020 Apr 02, 2022 This announcement has multiple deadlines: Current Close Date : April 10, 2020, by 11:59 PM Eastern Time. April 3, 2021, by 11:59 PM Eastern Time. April 2, 2022, by 11:59 PM Eastern Time.
Last Updated Date: Jan 08, 2020
Award Ceiling: $5,000,000
Award Floor: $1,000,000
Estimated Total Program Funding: $10,000,000
Expected Number of Awards: 2
Description: BackgroundFDA regulates pharmaceutical drug products to ensure a continuous supply of high quality drugs in the United States. In regulating the pharmaceutical manufacturing sector, new technologies can improve drug quality, address shortages of medicines, and lower drug costs. To help achieve this, FDA encourages development and adoption of emerging manufacturing technology to modernize pharmaceutical manufacturing. Advanced manufacturing holds great promise for improving the American market for drugs and biologicals and, results in a more robust manufacturing process with fewer interruptions in production, fewer product failures (before or after distribution), and greater assurance that the drug products manufactured in any given period of time will provide the expected clinical performance. In other words, encouraging the development and adoption of emerging manufacturing technologies may lead to improved manufacturing, and therefore improved product quality and availability throughout a product’s lifecycle.The complexity of drug products has been increasing over the years, in part due to, the increasing number of poorly soluble drugs, targeted drug delivery to traditionally un-druggable sites, and increasing focus on personalized and precision medicine. In the realm of drug products, complexity may arise from the active ingredient, the formulation, the dosage form, etc. In order to prepare for the increase in complex products, the Office of Pharmaceutical Quality is considering best practices and paths forward in the risk-based quality assessment of complex drug products. While the development of emerging technology is critical to modernizing pharmaceutical manufacturing and improving quality, FDA also recognizes that the implementation of emerging technology could present challenges to both industry and FDA. By the very nature of an approach being new or innovative in pharmaceutical industry, a limited knowledge and experiential base about the technology may exist. This program aims to address knowledge and experience gaps identified for emerging manufacturing technology and support the development and adoption of such technology in the pharmaceutical sector.Project ObjectivesThe goal of this program is to support the advancement of regulatory science that can (1) facilitate the implementation and the assessment of emerging manufacturing technology in the pharmaceutical sector; (2) expand the knowledge base related to complex products and formulation development, analysis, and manufacturing control to advance risk-based quality assessment of new and generic drug productsIdentified emerging technologies should be sufficiently developed and likely ready for industrial implementation for the purpose of product quality enhancement. The results and knowledge developed in this program can be utilized by industry, academia, and industry to support the implementation of the identified emerging technologies and to ensure that FDA regulatory policies reflect state-of-the-art manufacturing science. Specifically, the expected project outcomes should enable (1) developing tools and approaches for risk-based quality assessment, (2) establishing science-based quality standards and policies, and/or (3) providing training tools for both the industry and/or the regulatory bodies for the identified emerging technology.Potential research projects could include those that focus on characterizing complex drug substances (including botanical drug substances) and complex drug product dosage forms. Projects could include related control strategies to ensure the product quality, especially those which can help solve potential regulatory questions related to drug quality. Specific topics could relate to the following:1. Appropriate analytical methods for complex drug substances or products2. In-process controls during manufacturing processes to ensure product quality3. Raw material quality controlNOTE: Proposals should clearly describe the potential impacts of the proposed technology on readiness for broad implementation in pharmaceutical industry, control strategy, and/or regulatory evaluation for complex drug substances and complex drug product dosage forms.
Version: 2
Modification Comments: Close Date Explanation

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