20 security-"https:"-"https:" Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Quantitative Systems Pharmacology Modeling for Fetal Cardiac Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

turn this project will advance safety and understanding of potential toxicity of FDA-regulated products in the perinatal population. Learning Objectives: Under the guidance of the mentor, you will gain

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

: This research project will examine the use of nonclinical in vitro studies to evaluate drug safety and support regulatory decision-making. Research involves using state-of-the-art automated patch clamp

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

-the-counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines. Research Project: Pediatric developmental safety studies in drug

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 22 hours ago

, there are only animal data to inform the safety in pregnant and lactating women. Pregnancy safety and lactation data are collected predominantly in the post approval setting. The 2007 FDA Amendments Act gave FDA

FDA Utilizing Artificial Intelligence to Enhance Pharmacovigilance and Inspection Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

intelligence-enabled opioid pharmacovigilance and inspection software application that advances drug safety surveillance by integrating real-world data and regulatory data. The new comprehensive multi-resource

FDA In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

research questions involving challenging active/inactive ingredients, sophisticated formulations, and innovative dosage forms; 3) Advanced human subject safety for bioequivalence trials - Conduct meta

FDA Large Language Models (LLM) for Case Definition Classification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

 contribute to projects that are mandated under the 21st Century Cures Act (2016) Section 3022 (Drug Safety) to evaluate real-world evidence data on drug’s use or risks from sources other than clinical trials

FDA Research Fellowship: Biologic Products and the Regulatory Evaluation of Biosimilars

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

products, with no clinically meaningful differences in safety, purity, or potency. Despite advances in analytical and functional characterization, establishing a robust quantitative link between analytical

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. Research Project: The Office of New Drugs (OND) is responsible for assessing safety and

FDA Fellowship - Development and Validation of AI Prompts to Summarize Industry Submissions

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 22 hours ago

industry submissions. Learning Objectives: You will join generations of scientists in the field of pharmacoepidemiology, pharmacovigilance, and drug safety through this learning opportunity. You will receive