Enhancing Regulatory Science for Advancing Pharmaceutical Quality and Manufacturing (U01) Clinical Trials Optional
FDA - Food and Drug Administration (PAR-20-083)
- Proposal: 04/10/2020
- Amount: Up to $1m per year
- Duration: 5 years
The goal of this program is to support the advancement of regulatory science that can (1) facilitate the implementation and the assessment of emerging manufacturing technology in the pharmaceutical sector; (2) 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
Identified emerging technologies should be sufficiently developed and likely ready for industrial implementation for the purpose of product quality enhancement. The results and knowledge developed in this program can be utilized by industry, academia, and industry to support the implementation of the identified emerging technologies and to ensure that FDA regulatory policies reflect state-of-the-art manufacturing science. Specifically, the expected project outcomes should enable (1) developing tools and approaches for risk-based quality assessment, (2) establishing science-based quality standards and policies, and/or (3) providing training tools for both the industry and/or the regulatory bodies for the identified emerging technology.
Potential research projects could include those that focus on characterizing complex drug substances (including botanical drug substances) and complex drug product dosage forms. Projects could include related control strategies to ensure the product quality, especially those which can help solve potential regulatory questions related to drug quality. Specific topics could relate to the following:
1. Appropriate analytical methods for complex drug substances or products
2. In-process controls during manufacturing processes to ensure product quality
3. Raw material quality control
NOTE: Proposals should clearly describe the potential impacts of the proposed technology on readiness for broad implementation in pharmaceutical industry, control strategy, and/or regulatory evaluation for complex drug substances and complex drug product dosage forms.
Eligibility & Submission Requirements
A technical session will be held for prospective applicants in MARCH 2020. Subsequent technical sessions will be held approximately 30-45 days prior to the applicable application due date. The conference call information will be provided to prospective applicants that submit a letter of intent by February 28th. The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process. Participation in the technical session is optional, but strongly encouraged.
OPQ Extramural Program
Center for Drug Evaluation and Research (CDER)