In vitro release tests for transdermal drug delivery systems (U01)

Funding Opportunity Number: RFA-FD-13-015 Opportunity Category: DiscretionaryFunding Instrument Type: Cooperative AgreementCategory of Funding Activity: HealthScience and Technology and other Research and DevelopmentCFDA Number: 93.103Eligible Applicants County governmentsCity or township governmentsNative American tribal governments (Federally recognized)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 educationNonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher educationFor profit organizations other than small businessesOthers (see text field entitled "Additional Information on Eligibility" for clarification)Agency Name: HHS-FDAClosing Date: Jun 01, 2013Award Ceiling: $500,000Expected Number of Awards: 7Creation Date: May 07, 2013Funding Opportunity Description: Background Many transdermal delivery systems (TDDS) are labeled to warn against applying heat to the TDDS as it may increase the rate of drug release. When the reference product contains these warnings, the generic product must also have the same labeling. As part of its review FDA does require evidence that the formulation of a generic product is not less safe than the RLD. It is possible that different transdermal formulations of the same drug may have different responses to heat. To ensure that the RLD ...
Source: Grants.gov - Category: Research Tags: Health Science and Technology and other Research and Development Source Type: funding