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

FDA Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 4 hours ago

understanding of HLA-restricted T-cell activation. Learning Objectives: Under the guidance of a mentor, you will gain experience in and learn to: Identify Impurity-Derived Neoepitopes via Immunopeptidomics Define

FDA Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

analysis, web-scraping, and traditional statistical methods. This will transform OQS surveillance operations while providing educational opportunities for staff to learn about the regulatory landscape and

FDA Research Fellowship: Biologic Products and the Regulatory Evaluation of Biosimilars

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

or limited multivariate analysis. However, the increasing dimensionality and complexity of analytical data demand AI/ML-based frameworks capable of learning nonlinear, high-dimensional relationships between

FDA Developing Novel Technologies for Identification/Characterization of Glycans on Glycoproteins

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

release from glycoprotein drugs with chemo-enzymatic methods and characterize glycan structures with state-of-the-art technologies, including H(U)PLC and mass spectrometry (MS). Learning Objectives: Under

FDA Over the Counter Drug Monograph Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

, or sunscreens to support monograph development and updates. Participants will engage in learning opportunities through mentored training sessions focused on OTC drug monograph research methodologies and

FDA Clinical Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

on how co-use should be evaluated for impairment. Learning Objectives: The fellowship will provide structured learning opportunities in clinical pharmacology, pharmacokinetics, regulatory science

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 4 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 Product Specific Guidance and Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 3 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 4 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 4 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