69 affective-computing-"https:"-"https:"-"https:" positions at Center for Drug Evaluation and Research (CDER)

FDA Computational Toxicology fellowship

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

of funds. Level of Participation: The appointment is full time. Citizenship Requirements: This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only. This program, administered

FDA Computational Toxicology Fellowship

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

. Learning Objectives: Under the guidance of a mentor, the participant will learn about the development of computational models for regulatory use. Research and training activities may include: Learning

FDA Computational Biology and Pharmacology Fellowship

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

validation of human-based in vitro and computational methods submitted to FDA for regulatory use. The developed models will be used to predict various toxicity endpoints and drug exposure to help provide

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 | 2 days ago

, particularly disparities affecting Black populations in breast and prostate cancers. Mentor: The mentors for this opportunity are Dr. Salimi Ashkezari (SeyedehFatemeh.SalimiAshkezari@fda.hhs.gov ) and Dr. Ling

FDA Bioequivalence of Complex Generic Products Fellowship

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

can impact the performance of test products to their respective reference listed drug. It will also identify potential scientific gaps in the application of novel technologies for characterizing complex

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 | 2 days ago

analyze the impact of these changes on regulatory decision-making. During the project, you will help: Collect comprehensive data on dosage optimization strategies from recently approved oncology New Drug

FDA Quantitative Systems Pharmacology Modeling for Fetal Cardiac Safety Fellowship

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

health concern, with potential long-term implications for affected individuals. Studies have identified a possible association between the use of antidepressants during pregnancy and an increased risk of

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

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

translational strategies to facilitate leveraging in vitro data and cutting-edge scientific information to yield regulatory solutions that directly impact human health and drug development efficiency. Results

FDA Product Specific Guidance and Research Fellowship

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

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 | 2 days ago

/product-related impurities) may alter immunogenicity risk and affect safety, pharmacokinetics, pharmacodynamics, and efficacy. Current FDA guidance (e.g., the 2021 guidance for certain highly purified