48 developer-"https:"-"https:"-"https:"-"LGEF" Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Utilizing Artificial Intelligence to Enhance Pharmacovigilance and Inspection Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 days ago

for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA), located in Silver Spring, Maryland. Research Project: The focus of the project will be on developing an artificial

FDA Product Specific Guidance and Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 days ago

from FDA-funded scientific research can be used to support PSG development. This project includes the development of knowledge management and research management tools to maintain, monitor, and analyze

FDA Fellowship - Sex Differences in Efficacy/Safety Outcomes of HIV Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 13 days ago

develop technical skills in R programming and data interpretation. Develop skills in scientific data analysis, identification of research biases and limitations, effective communication of research

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 days ago

quantitative method support for guidance development, abbreviated new drug application (ANDA) reviews, citizen petitions, controlled correspondence, pre-ANDA meetings, methodology development for bioequivalence

FDA Fellowship - Clinical Pharmacology Considerations for Novel Therapeutic Modalities

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 days ago

to their novelty and rapid evolution. The research aims to facilitate product development, assist review decision-making, identify regulatory knowledge gaps, and support evidence-based evaluation approaches

FDA Computational Toxicology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 days ago

drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. Research Project: This research project aims to develop quantitative structure-activity relationship

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 days ago

developing comprehensive databases to systematically evaluate the current landscape of in vitro data utilization in drug development. This research will contribute to the development of innovative

FDA Fellowship - Enhancing Oncology Dose Optimization Through Patient-Reported Outcome Exposure-Response Analysis

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 13 days ago

(PROs) represent the only quantitative tool available to assess tolerability of oncologic agents under development, providing unique insights into the patient experience of symptomatic adverse events

FDA Bioequivalence of Complex Generic Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 days ago

under abbreviated new drug applications (ANDAs) and NDAs. The project will identify and develop in vitro, in vivo, or in silico techniques that may be capable of determining how various complexity factors

FDA High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 13 days ago

both the development and regulation of oligonucleotide drugs. Learning Objectives: Under the guidance of the mentor, you will receive instructions on utilizing chromatography, mass spectrometry, and