18 multiple-sequence-alignment positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Consistent Approach to Maximum Daily Dose Determination

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 2 months ago

to systematically collect and analyze MDD determinations made within the past five years across multiple offices and divisions. Learn to assess alignment and discrepancies between historical MDD determinations, other

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 6 hours ago

clinical trials when bioequivalence and qualitative comparability to the reference product are demonstrated. However, differences in product quality attributes (including sequence variants and process

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 6 hours ago

clinical data from multiple sources within FDA's information systems. You will gain regulatory science experience and policy development insight that supports advancement in clinical pharmacology, drug

FDA Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 6 hours ago

development for inflammatory bowel disease (IBD). Since the approval of infliximab for Crohn’s disease in 1998, multiple advanced therapies—including ten biologics and four small molecules—have been approved

FDA Fellowship - Endpoint Strategy Selection and Statistical Analysis Plan for Non-Malignant Hematologic Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 6 hours ago

analyses from recent submissions/literature with emphasis on clinical interpretability, multiplicity control, estimands, and alignment with common regulatory expectations. Analyze operating characteristics

FDA Statistical Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

, noninferiority trials, multiple endpoints, adaptive designs, Bayesian design and analysis methods, estimands, meta-analyses, benefit-risk analyses, subgroup analyses, biosimilars, patient experience data

FDA Fellowship in Regulatory Science Advancement for Continuous Glucose Monitoring (CGM) Endpoints

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

of CGM-derived metrics (e.g., Time in Range (TIR)) relative to hemoglobin A1c (A1C) across multiple clinical trials, calculating and interpreting trial-level correlations across diverse study populations

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

nonclinical data (such as chemical structures, sequences, and in vitro functional assays for specific drugs) into safety endpoints (such as cardiotoxicity, immunogenicity, etc.) Learning Objectives: As a

FDA Fellowship in Regulatory Science Advancement for Continuous Glucose Monitoring (CGM) Endpoints

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

of CGM-derived metrics (e.g., Time in Range (TIR)) relative to hemoglobin A1c (A1C) across multiple clinical trials, calculating and interpreting trial-level correlations across diverse study populations

FDA Fellowship in Statistical Methods for New Approach Methodologies (NAMs)

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

statistical methods for evaluating parallelism of dose-response curves between test and reference standards through simulation studies. Evaluation of multiple statistical approaches — including logistic