8 Design Fellowship positions at Center for Drug Evaluation and Research (CDER) in united-state in United States

FDA Bioinformatics Fellowship

on the following topics: The fundamentals of how FDA CDER reviewers interpret toxicology study results The SEND data standard and how it maps onto toxicology study design and results Development of R scripts

FDA Bioequivalence of Complex Generic Products Fellowship

products with device components that may themselves have degrees of complexity in design. In addition, the participant will gain knowledge in collaborating with cross-disciplinary teams to develop novel in

FDA Fellowship in Comparative Gaps Analysis in Sickle Cell Disease

the SCD community. The project is designed to address these gaps through strategic analysis between the clinical trial data that supported FDA approved for SCD therapeutic products and real world data

FDA In Vitro and In Vivo Bioequivalence Fellowship

polymer-based drugs, oral inhaled and nasal products, topical and transdermal drugs, and combination drug-device products with device components that may themselves have degrees of complexity in design. In

FDA-CDER Fellowship in the Intranasal Administration of Monoclonal Antibodies and other Biological Therapeutics

thinking, experimental design and aseptic technique and gain specialized skills including cell culture, immunohistochemistry, real-time PCR, and western blotting. Additionally, the participant will have

CDER Fellowship in Natural History for Rare Pediatric Viral Disease

events and clinical response to the duration of antiviral treatment course and c) obtain insights for possible endpoints, including biomarkers (e.g. CMV viral load) that might help future study designs

FDA Fellowship in Program, Policy and Operational Analysis

, designs and implements new programs, advances structured benefit-risk assessment in regulatory decision making and evaluates key business processes using evidence-based approaches that assess the value

FDA Oligonucleotide Research Fellowship

entail executing experimental designs, conducting laboratory analyses to develop analytical methods comprehensively, and gaining insight into drug development and product quality control. Additionally