Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01)

The summary for the Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (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 Drug Administration, which is the U.S. government agency offering this grant.
Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01): 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.
Federal Grant Title: Limited Competition for Revision Applications for Pharmacometric Modeling and Simulation for Generic Drugs Evaluation (U01)
Federal Agency Name: Food Drug Administration
Grant Categories: Consumer Protection Food and Nutrition Health
Type of Opportunity: Mandatory
Funding Opportunity Number: RFA-FD-15-032
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: May 29, 2015
Original Application Deadline: May 29, 2015
Posted Date: Mar 24, 2015
Creation Date: Mar 24, 2015
Archive Date: Jun 28, 2015
Total Program Funding: $250,000
Maximum Federal Grant Award: $250,000
Minimum Federal Grant Award: none
Expected Number of Awards: 1
Cost Sharing or Matching: No
Applicants Eligible for this Grant
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
Grant Announcement Contact
Lisa Ko Grants Management Specialist
lisa.ko@fda.hhs.gov

Food & Drug Administration 301-443-5869
Similar Government Grants
FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed)
Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed)
Rare Disease Clinical Outcome Assessment Consortium (U01 Clinical Trial Not Allowed)
Cigar Tobacco Reference Products Program (UC2) Clinical Trials Not Allowed
Implementation of U.S. Food Safety Modernization Act - Identifying, Researching, and Imple...
Support for Small Scientific Conference Grant Program
Cooperative Agreement to Support the World Health Organization (WHO) International Program...
Clinical Studies of Safety and Effectiveness of Orphan Products
More Grants from the Food Drug Administration
NARMS Cooperative Agreement Program to Enhance and Strengthen Antibiotic Resistance Survei...
Cooperative Agreement to Support Shellfish Safety Assistance Project (U01)
Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA C...
Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food ...
National Training, Education, Extension, Outreach, and Technical Assistance Competitive Gr...

FederalGrants.com is not endorsed by, or affiliated with, any government agency. Copyright ©2019 FederalGrants.com