25 data-"https:"-"https:"-"https:"-"https:"-"https:" Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Development of AI Technologies for Causality Assessment

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | 30 minutes ago

for causality assessments of individual case safety reports. The research project is supported under 21st Century Cures Act (2016) Section 3022 (Drug Safety) to evaluate real-world evidence data on drug’s use

FDA Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 23 minutes ago

macular edema (DME), with potential expansion to other retinal indications, through network meta-analysis and patient matching methodologies applied to historical and recent clinical data. The participant

FDA Research Fellowship: Neurodevelopmental Assessment of Prenatal Analgesic Exposure Using Translational Models

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | 20 minutes ago

of great interest to CDER. The resulting data may impact guidelines over the use of a drug of interest in pregnancy. The National Center for Toxicological Research (NCTR) is currently investigating

FDA Postdoctoral Fellowship in the Application of Microphysiological Systems to Study the Blood-Milk Barrier

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 28 minutes ago

barrier integrity and permeability, and compare in vitro findings with available clinical and pharmacokinetic data to assess model performance. These activities will advance understanding of maternal–infant

FDA Fellowship - In Silico and In Vitro Approaches to Inform Polypharmacy and Patient Effects on Opioid Overdose

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 21 minutes ago

and become efficient in using various computing languages, such as R, C, and Python, to develop mechanistic models to simulate human pharmacology and utilize High Performance Computing for data analysis

FDA Fellowship - Strategies to Identify Cases of Prenatal Drug Exposure in FAERS

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 24 minutes ago

-on training to retrieve data from relevant FDA databases and tools. Under the guidance of mentors, you will learn about regulations, policies, and procedures pertinent to postmarketing drug safety surveillance

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 22 minutes ago

pediatric drug development of these products. The selected fellow will be involved in the following activities related to the research project: collecting data from public and proprietary sources, analyzing

FDA Fellowship - Clinical Pharmacology Considerations for Novel Therapeutic Modalities

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 29 minutes ago

competencies in research methodology, data analysis, scientific presentation, and manuscript writing skills that support career advancement in regulatory science, pharmaceutical development, or academic research

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 | 28 minutes ago

nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program website for information about the valid immigration statuses that are acceptable

FDA Fellowship - Endpoint Strategy Selection and Statistical Analysis Plan for Non-Malignant Hematologic Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 24 minutes ago

under realistic data-generating scenarios (endpoint correlation, effect assumptions, alpha requirements), compare study power and other metrics (e.g., probability that endpoints are individually