Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns (U01)

The summary for the Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns (U01): With the significant increase of generic market share, it is becoming imperative that the public and the scientific community have confidence that the FDA review of generic drugs will ensure that a generic drug is interchangeable with the brand product as well as other generics under all approved indications and conditions of use. Some complex generic products such as vancomycin capsules, sodium ferric gluconate injection, enoxaparin injection and others are approved based on innovative but controversial methods. The purpose of this study is to evaluate existing tools and to develop new methods to proactively monitor the drug safety, efficacy, usage, and substitution patterns of recently approved generic drugs whose approval was controversial and to evaluate if controversy during the approval process affects their acceptance by physicians and patients. The outcome of this study will help assure the public about generic drug safety and efficacy, and support the Agency to continue developing innovative methods for generic drug product approval.
Federal Grant Title: Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns (U01)
Federal Agency Name: Food and Drug Administration
Grant Categories: Consumer Protection Food and Nutrition Health
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-13-022
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: May 10, 2013
Original Application Deadline: May 10, 2013
Posted Date: Mar 29, 2013
Creation Date: Mar 29, 2013
Archive Date: Jun 09, 2013
Total Program Funding: $250,000
Maximum Federal Grant Award: $250,000
Minimum Federal Grant Award:
Expected Number of Awards: 1
Cost Sharing or Matching: No
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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Grant Announcement Contact
Lisa Ko Grants Management Specialist

[email protected] [[email protected]]
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