Notice Number: NOT-FD-14-002

Key Dates
Release Date: February 24, 2014

Issued by
Food and Drug Administration (FDA)

Purpose

This Notice is to inform potential applicants of the Food and Drug Administration (FDA) intent to publish a Funding Opportunity Announcement (FOA) to solicit applications for pharmacometric modeling and simulation for generic drugs evaluation, and allow sufficient time to develop meaningful collaborations and responsive projects. The FOA is expected to be published in March 2014 with an expected application due date in May/June 2014. Applications for this FOA will be electronic and be submitted through the Grants.gov. Applications are not being solicited at this time.

Research Initiative Details:

The purposes of this project are to develop quantitative models for generic drugs evaluation in the following areas (1) narrow therapeutic index (NTI) drugs, (2) generic drug substitutability and post marketing risk assessment, and (3) partial AUCs (area under the concentration vs. time curve) as bioequivalence criteria. Each area is a subtopic of the grant.

This Notice encourages teams with complementary expertise in quantitative pharmacometric modeling and simulation experience to consider applying for the new FOA when published.

Each applicant may apply to one or more of the subtopics listed above. Applicants who wish to apply for more than one subtopic should prepare separate proposals for each subtopic.

Inquiries

Please direct all inquiries to:

Xinyuan Zhang
Food and Drug Administration
Center for Drug Evaluation and Research/ Office of Generic Drugs
Phone: 240-276-8615
Email: Xinyuan.Zhang@fda.hhs.gov