60 evolution "https:" "https:" "https:" "https:" "https:" "https:" "University of Cambridge" positions at Center for Drug Evaluation and Research (CDER)

FDA Biomarker Analysis: Addressing the Gap Between Patient Enrollment Applications and Pharmacodynamic Effect Evaluation

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

generic drugs. These efforts cover more than just medicines. Research Project: Some biomarkers have been used as multiple roles through one drug development such as a diagnosis biomarker for patient

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

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

safety evaluators to discuss findings and their implications for regulatory policy development and review practices. Presenting research findings to the Division of Clinical Pharmacology and other

FDA High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 3 hours 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

FDA Advanced Evaluation of Postmarket Product Quality Reports

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

product quality signals. During the appointment, you will help explore important parameters in cluster and/or trend identification to help with the development of an algorithm that can be used for signal

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 4 hours ago

of pregnancy and lactation postmarketing requirement studies. Pregnant and lactating women have historically been excluded from drug development trials. Therefore, at the time of new drug/biologic approval

FDA Application of AI for Precision Medicine Fellowship

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

unstructured submission data for model development; 2) Apply AI methods to identify key clinical and biomarker features that drive response to therapy; 3) Contribute to manuscripts, reports, and presentations

FDA Utilizing Artificial Intelligence to Enhance Pharmacovigilance and Inspection Fellowship

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

the development of innovative AI architectures that graphically interconnect disparate biomedical information sources to address public health needs. Collaborating with interdisciplinary teams to investigate

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours 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 Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

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

mentorship. This experience will advance your development by providing structured research training applicable to pharmaceutical and regulatory science careers, facilitating professional network development

FDA Dosage Optimization of Antibody-Drug Conjugates

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

products and development programs. Participate in discussions with the Division of Cancer Pharmacology (DCP) leadership, clinical pharmacology reviewers, and team leads regarding how the results