Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations (U01) (RFA FD 18 010)

 

Opportunity Information:

  • The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations (U01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
  • This funding opportunity was created on Mar 21, 2018.
  • Applicants must submit their applications by May 21, 2018.
  • Each selected applicant is eligible to receive up to $250,000.00 in funding.
  • The number of recipients for this funding is limited to 2 candidate(s).
  • Eligible applicants include: State governments, 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, Individuals, For profit organizations other than small businesses, Small businesses.
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Applicants also applied for:

Applicants who have applied for this opportunity (RFA FD 18 010) also looked into and applied for these:

Funding Number Funding Title
RFA FD 18 019 Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems (U01)
RFA FD 18 020 Three-Dimensional Approach for Modeling Nasal Mucociliary Clearance via Computational Fluid Dynamics (CFD) (U01)
RFA FD 18 014 Computational fluid dynamics (CFD) and discrete element modeling (DEM) approach for predictions of dry powder inhaler (DPI) drug delivery (U01)
RFA FD 18 012 Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Non-Invasive Techniques (U01)
RFA FD 18 011 Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (U01)
RFA FD 18 021 Assuring Radiation Protection (U18)
RFA FD 18 016 Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance (U24)
RFD FD 18 018 Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01)
RFA FD 18 009 Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01)
RFA FD 18 013 Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act
RFA FD 18 022 Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01)
RFA FD 18 025 Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19)
RFA FD 18 018 Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01)
RFA FD 18 024 Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01)
PAR 18 827 Minor Use Minor Species Development of Drugs (R01)
RFI NOT FD 18 014 Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints
RFA FD 19 002 Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed)
RFA FD 19 005 Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional
RFA FD 19 014 Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code
RFA FD 19 008 Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed)

 

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