This grant is for the purpose of developing comprehensive methods to evaluate the impact of small design differences in the user interface of generic drug-device combination products, specifically when compared to their reference listed drug (RLD) counterparts. The research aims to thoroughly understand the factors related to these subtle user interface variations that affect generic substitutability among end-user groups. The insights gained from this investigation will provide a deeper understanding of the dynamics influencing the interchangeability of generic and branded drug-device combination products, ultimately contributing to informed regulatory practices and improved patient outcomes.
Opportunity ID: 327602
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | FOR-FD-20-013 |
| Funding Opportunity Title: | Development of methods for evaluating the impact of small design differences in the user interface of drug-device combination products on generic substitutability |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 25, 2021 |
| Last Updated Date: | May 25, 2021 |
| Original Closing Date for Applications: | – Archiving forecast |
| Current Closing Date for Applications: | – Archiving forecast |
| Archive Date: | May 26, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities State governments County governments Special district governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Small businesses Individuals For profit organizations other than small businesses |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of the research is to develop methods for evaluating the impact of small design differences in the user interface of generic drug-device combination products when compared to the user interface of the reference listed drug (RLD). The results obtained from this research will be used to gain a better understanding of the factors related to small design differences in the user interface that impact substitutability between generic and branded drug-device combination products in end-user groups. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Shashi Malhotra
Grants Management Specialist Email:shashi.malhotra@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
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