6 evolution-"https:"-"https:"-"https:"-"https:"-"https:"-"U.S" positions at Center for Drug Evaluation and Research (CDER)

FDA Clinical Pharmacology / Model Informed Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 8 hours ago

, biomarkers, and model-informed drug development (MIDD) approaches inform final dose selection. Key activities will include reviewing FDA regulatory documents such as Pre-IND communications, End-of-Phase 2 and

FDA Development of Analytical Methods to Assess Nitrosamine Impurities in Over-the-Counter (OTC) Monograph Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 8 hours ago

the following areas: Development and validation of analytical procedures to assess the qualities of pharmaceutical product. Application of advanced analytical techniques mainly LC-MS in pharmaceutical analysis

FDA Bayesian Statistical Approaches to Address the Unique Challenges of Rare Disease Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 8 hours ago

disease drug development within FDA's regulatory framework. You and mentors will research Bayesian dynamic borrowing methods for augmenting small sample sizes through incorporation of historical data

FDA Fellowship - Development and Validation of AI Prompts to Summarize Industry Submissions

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 8 hours ago

disorders, pharmacovigilance, pharmacoepidemiology methods development). Mentor: The mentor for this opportunity is Jason Flint, MBA, PMP, (Jason.Flint@fda.hhs.gov ). If you have questions about the nature

FDA Development of Cell-based Reporter Assays for FSH, LH and hCG

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 8 hours ago

the chance to: Gain knowledge about reproductive hormone therapies. Gain knowledge about development of cell-based bioassays. Perform hands-on experiment to learn laboratory techniques including cell

FDA Pediatric Drug Development Programs for Drug-Device Combination Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

challenge to pediatric drug development especially for the younger children. Some of the challenges in using pediatric drug-device combination products include the delivery of inadequate doses for achieving