25 evolution-"https:"-"https:"-"https:"-"https:"-"https:"-"https:"-"CERIC-ERIC" positions at Center for Drug Evaluation and Research (CDER)

FDA Pediatric Drug Development Programs for Drug-Device Combination Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

challenge to pediatric drug development especially for the younger children. Some of the challenges in using pediatric drug-device combination products include the delivery of inadequate doses for achieving

FDA Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 8 hours ago

documents and to evaluate how dosing strategies are utilized for oncology drugs in pediatric patients. Findings from this project will inform the development of regulatory policy aimed at refining pediatric

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 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 Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 8 hours ago

to the development of evidence-based guidance for oncology drug dosing in patients with obesity. Gain hands-on experience with data analysis/platforms and knowledge of regulatory science and oncology drug development

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 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 High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 8 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 Over the Counter Drug Monograph Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

, or sunscreens to support monograph development and updates. Participants will engage in learning opportunities through mentored training sessions focused on OTC drug monograph research methodologies and

FDA Evaluating the Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

to drugs in the breastfed infant. This project focuses on development of PBPK models for LAI drug products (e.g., antiretroviral drugs and psychiatric drug products). The anticipated project outcomes

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 8 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 Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

development have been restricted to juvenile animal studies for the past 20 years. The FDA program to reduce, refine and replace animal studies has stimulated an important discussion about both increasing