The FDA is offering a grant to develop pharmacometric modeling and simulation tools for evaluating generic drug substitutability and post-marketing risk assessment. The expansion of the awarded study focuses on risk-based methodology for generic equivalents of reference list drugs prone to switching issues, aiming to predict products susceptible to post-marketing bioinequivalence. Applications are invited to enhance pharmacometric approaches aiding the Office of Generic Drugs in assessing post-market risk and interpreting adverse event reports or product substitution complaints. Closing date for submissions is May 29, 2015.
Opportunity ID: 275352
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-032 |
| Funding Opportunity Title: | Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01) |
| Opportunity Category: | Mandatory |
| 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 24, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | May 29, 2015 |
| Current Closing Date for Applications: | May 29, 2015 |
| Archive Date: | Jun 28, 2015 |
| Estimated Total Program Funding: | $250,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Only the following organization is eligible to apply: UNIVERSITY OF FLORIDA |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | The primary objective of original RFA-FD-14-011 (subtopic 2) is to develop pharmacometric modeling and simulation tools for generic drug substitutability evaluation and post marketing risk assessment. The goal is to develop pharmacometic approaches (including clinical trial simulation and clinical use/substitution simulation) that will aid OGD in the evaluation of post-market risk and the interpretation of post-market adverse event reports or product substitution complaints. The scope of the awarded study is being expanded to risk-based methodology on generic equivalents of the reference list drugs (RLDs) that may be most susceptible to “with cause” switching issues (e.g., modified release oral dosage forms” or “patient perception” of switching issues where differences in efficacy or safety can be readily perceived in clinical practice (e.g., anticoagulants). The risk-based methodology will be applied to predict which generic product is most likely to encounter switching issues, and least likely to demonstrate post-marketing bioinequivalence. |
| Link to Additional Information: | – |
| 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
Folder 275352 Full Announcement-1 -> rfd-fd-15-032 program expansion ufl (lesko) final 3.23.15.pdf
Folder 275352 Full Announcement-1 -> sf424_rr_guide_general_adobe_verc.pdf
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 | PKG00215729 | Mar 27, 2015 | May 29, 2015 | View |
Package 1
Mandatory forms
275352 RR_SF424_2_0-2.0.pdf
275352 PHS398_ResearchPlan_2_0-2.0.pdf
275352 PHS398_CoverPageSupplement_2_0-2.0.pdf
275352 RR_Budget_1_3-1.3.pdf
275352 RR_KeyPersonExpanded_2_0-2.0.pdf
275352 RR_OtherProjectInfo_1_3-1.3.pdf
275352 PerformanceSite_2_0-2.0.pdf
Optional forms
275352 PlannedReport-1.0.pdf
275352 PHS398_CumulativeInclusionReport-1.0.pdf
275352 RR_SubawardBudget30_1_3-1.3.pdf
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