78 machine-learning "https:" "https:" "https:" "https:" "https:" "https:" "https:" "Univ" "Univ" positions at Center for Drug Evaluation and Research (CDER)

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 | about 9 hours ago

variety of advanced analytical and bioanalytical assays from method development to experimental or test sample analysis including the process of method validation. Learning Objectives: Computational

FDA Product Specific Guidance and Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 9 hours ago

how the impact of outcomes from a scientific research program can be maximized to support future decision making. Learning Objectives: You will gain insight into the FDA's Office of Generic Drugs, and

Comparing Neonatal Adverse Drug Events from the Literature with FDA Labels

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 9 hours ago

. Learning Objectives: Under the guidance of the mentor, you will develop the following skills during the fellowship; Develop advanced information search strategies to identify and organize data relevant

FDA Regulatory Analysis of Dose-Finding and Optimization Approaches in Targeted Oncology Therapeutics

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 9 hours ago

the results of the project and their conclusions to the DCP and/or a broader clinical pharmacology audience. Contribute to a manuscript regarding the results of the project. Learning Objectives: During

FDA Research Opportunity - Analysis of Patient Diversity and Ineligibility Rates in Cancer Pivotal Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 9 hours ago

prevalence data, and evaluating ineligibility rates by race and ethnicity. The project will examine at least 20 drugs/trials and may stratify analyses by U.S. versus non-U.S. sites. Learning Objectives: You

FDA In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 9 hours ago

substitutability evaluation. Learning Objectives: Under the guidance of the mentor, you will gain a comprehensive understanding of the scientific and regulatory challenges that must be considered when establishing

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 9 hours ago

industry submissions. Learning Objectives: You will join generations of scientists in the field of pharmacoepidemiology, pharmacovigilance, and drug safety through this learning opportunity. You will receive

FDA Regulatory Science Research Project Related to Safety of Medications in Pregnancy in the Post Approval Setting

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 9 hours ago

addresses the need to improve data collection in pregnant and lactating women. Learning Objectives: This appointment provides structured learning through FDA courses and training on drug development topics

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 9 hours ago

product characteristics on the effectiveness of search strategies. Learning Objectives: You will learn best practices in drug and biological product post-market safety surveillance and receive hands

FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 9 hours ago

activities related to the research project: participate in data collection from public and proprietary sources, analyze research data, and contribute to presentation/publication of research findings. Learning