FDA Fellowship - Consistent Approach to Maximum Daily Dose Determination

About the role

The FDA Fellowship focuses on developing a consistent approach to Maximum Daily Dose (MDD) determination for generic drug products. This project aims to address inconsistencies in MDD determinations across different offices and divisions within the Center for Drug Evaluation and Research (CDER).

Responsibilities

• Learn the regulatory importance of MDD determinations for generic drug products and their role in safety evaluations.
• Systematically collect and analyze MDD determinations made within the past five years across multiple offices and divisions.
• Assess alignment and discrepancies between historical MDD determinations, other CDER office decisions, and existing regulatory databases.
• Create and propose a consistent, science-based approach for determining and documenting MDD values.
• Design and implement a centralized database (DCR MDD database) to warehouse and standardize MDD information.

Requirements

This opportunity is available to U.S. citizens only. The candidate should have received a master's or doctoral degree in life health and medical sciences within the last five years. A strong background in pharmacology with clinical experience is preferred.

Qualifications

The candidate should have:

• A master's or doctoral degree in life health and medical sciences.
• U.S. citizenship.

Skills

Preferred skills include:

• A strong background in pharmacology with clinical experience.

Benefits

No specific benefits are mentioned in the job posting.

Pay

The participant will receive a monthly stipend commensurate with educational level and experience.

Schedule

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.