Development of methods for evaluating the impact of small design differences in the user interface of drug-device combination products on generic substitutability

0
108

Opportunity ID: 327602
Opportunity Number: FOR-FD-20-013
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:
CFDA Number(s): 93.103
Eligible Applicants: 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
Additional Information on Eligibility:
Agency Code: HHS-FDA
Agency Name: Department of Health and Human Services
Food and Drug Administration
Posted Date: Jun 09, 2020
Last Updated Date: Jun 09, 2020
Estimated Synopsis Post Date:
Fiscal Year: 2021
Award Ceiling:
Award Floor:
Estimated Total Program Funding:
Expected Number of Awards:
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.
Version: 1





Visit the Official Webpage For More Details on Development of methods for evaluating the impact of small design differences in the user interface of drug-device combination products on generic substitutability