This grant focuses on developing and evaluating methods for proactive postmarketing surveillance of generic drugs. With the increasing generic market share, ensuring public and scientific confidence in their interchangeability, safety, and efficacy is paramount. This initiative will specifically monitor recently approved generic drugs, particularly those with controversial approval processes, to assess their real-world usage, substitution patterns, and acceptance by physicians and patients. The study aims to enhance existing tools and create new methodologies for ongoing drug safety monitoring. The findings will strengthen public assurance regarding generic drug safety and effectiveness, while supporting the Agency’s continued development of innovative approval processes for generic products. This ensures consumer confidence in all approved indications and conditions of use.
Opportunity ID: 228554
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-022 |
| Funding Opportunity Title: | Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Mar 29, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | May 10, 2013 |
| Current Closing Date for Applications: | May 10, 2013 |
| Archive Date: | Jun 09, 2013 |
| Estimated Total Program Funding: | $250,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts State governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public and State controlled institutions of higher education Small businesses Private institutions of higher education |
| 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. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | 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. |
| Link to Additional Information: | Link to Full Announcement of RFA-FD-13-022 on the NIH Guide for Contracts and Grants |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Lisa Ko Grants Management Specialist Email: lisa.ko@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | PKG00171774 | Apr 08, 2013 | May 10, 2013 | View |
Package 1
Mandatory forms
228554 RR_SF424_1_2-1.2.pdf
228554 PerformanceSite_1_4-1.4.pdf
228554 RR_OtherProjectInfo_1_3-1.3.pdf
228554 RR_KeyPersonExpanded_1_2-1.2.pdf
228554 RR_Budget-1.1.pdf
228554 PHS398_CoverPageSupplement_1_4-1.4.pdf
228554 PHS398_ResearchPlan_1_3-1.3.pdf
228554 PHS398_Checklist_1_3-1.3.pdf
Optional forms
228554 RR_SubawardBudget30-1.2.pdf
228554 PHS_CoverLetter_1_2-1.2.pdf
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