Evaluation of oral modified release drug tablet to support the approval of additional strengths
The summary for the Evaluation of oral modified release drug tablet to support the approval of additional strengths grant is detailed below.
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Evaluation of oral modified release drug tablet to support the approval of additional strengths: The FDA guidance, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (Aug 2021), provides recommendations for demonstrating the bioequivalence of additional strengths of a proposed modified release drug product. The recommendations involve evidence to demonstrate the same drug release mechanism and similar dissolution profiles across strengths, as well as ratios of drug excipients across strengths that are appropriate for the drug release mechanism. The purpose of this project is to determine the critical quality attributes for different release controlling platform technologies and to determine the appropriate factors to scale the formulation for additional strengths. The outcomes of this research are intended to support generic drug development and regulatory decision making.
Federal Grant Title: | Evaluation of oral modified release drug tablet to support the approval of additional strengths |
Federal Agency Name: | Food and Drug Administration (HHS-FDA) |
Grant Categories: | Consumer Protection Science and Technology |
Type of Opportunity: | Discretionary |
Funding Opportunity Number: | RFA-FD-23-013 |
Type of Funding: | Cooperative Agreement |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Information not provided |
Current Application Deadline: | March 15th, 2023 |
Original Application Deadline: | March 15th, 2023 |
Posted Date: | December 1st, 2022 |
Creation Date: | December 1st, 2022 |
Archive Date: | April 14th, 2023 |
Total Program Funding: | $450,000 |
Maximum Federal Grant Award: | $450,000 |
Minimum Federal Grant Award: | $50,000 |
Expected Number of Awards: | 1 |
Cost Sharing or Matching: | No |
Last Updated: | December 1st, 2022 |
- Applicants Eligible for this Grant
- 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 - 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:Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian 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)Local 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)
- Link to Full Grant Announcement
- FULL ANNOUNCEMENT
- Grant Announcement Contact
- Shashi Malhotra
Grants Management Specialist
Phone 2404027592
[email protected] - Similar Government Grants
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