Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional

Funding Agency:
National Institutes of Health

 The purpose of this program is to support research activities that expand the knowledge base related to complex products and formulation development, analysis, and manufacturing control to advance risk-based quality assessment of new and generic drug products. We will also consider biological products relevant to CDER (e.g., monoclonal antibodies and therapeutic proteins) for this announcement.       


Application Due Date(s): April 22, 2019


RFA-FD-19-011 Expiration Date April 23, 2019

Agency Website



Amount Description

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

YR 01: $1,000,000

YR 02: $1,000,000

YR 03: $1,000,000

Funding Type





Medical - Basic Science
Medical - Clinical Science
Medical - Translational

External Deadline

April 22, 2019