43 positions at Center for Drug Evaluation and Research (CDER) in United States

Applying Large Language Models (LLM) in Drug Safety Reviews Fellowship

*Applications will be reviewed on a rolling basis This project is in the Office of Pharmacovigilance and Epidemiology (OPE), Office of Surveillance and Epidemiology (OSE). This project will evaluate the performance of LLMs in selected literature review tasks (i.e., literature screening,...

Anti-infective Fellowship: Pediatric Clinical Pharmacology

*Applications will be reviewed on a rolling basis This project is located in the Office of Infectious Diseases (OID), Office of New Drugs (OND). The project seeks to address multiple challenges with the development of anti-infective drugs for pediatric use. Specifically, the results of the...

Clinical Pharmacology of Therapeutic Biologics and Biosimilars Fellowship

*Applications will be reviewed on a rolling basis This project is located in the Office of Clinical Pharmacology (OCP), Office of Translational Science (OTS). The FDA's published guidance documents outline general principles regarding how to use clinical pharmacology data to support a...

FDA Pharmacovigilance Fellowship: Data Retrieval and Analysis Strategies

*Applications will be reviewed on a rolling basis This project is in the Office of Pharmacovigilance and Epidemiology (OPE), Office of Surveillance and Epidemiology (OSE). This project will evaluate the utility and performance characteristics of different Medical Dictionary for Regulatory...

FDA Antimicrobial Pharmacology and Toxicology Fellowship

*Applications will be reviewed on a rolling basis The project is located in the Office of Infectious Diseases (OID), Office of New Drugs (OND). This project will use multiple approaches to evaluate existing nonclinical safety data of monoclonal antibodies directed against microbial targets and...

Drug Induced Liver Injury Mechanisms Fellowship

*Applications will be reviewed on a rolling basis This project is in the Office of New Drugs (OND), Immediate Office (IO).  This project will conduct regulatory research on drug induced liver injury (DILI) mechanisms using new approach methodologies (NAMs) such as micro physiological systems...

Advanced Manufacturing and Complex Drug Product Characterization / FDA-CDER-2024-1386

*Applications will be reviewed on a rolling-basis. The project is located in the Office of Testing and Research (OTR), Office of Pharmaceutical Quality (OPQ). The goal of the project is to determine the comparability of biosimilars and assess the impact of advanced manufacturing technologies on...

FDA-CDER Research Opportunity in Oncology Bioinformatics

*Applications will be reviewed on a rolling-basis. CDER Office/Lab and Location : A research opportunity is available in the Office of Oncologic Diseases (OOD), Office of New Drugs (OND), within the Food and Drug Administration (FDA) located in Silver Spring, Maryland. The Center for Drug...

FDA Research Fellowship in Large Language Models for Clinical Pharmacology

*Applications will be reviewed on a rolling-basis. CDER Office/Lab and Location : A research opportunity is available in the Office of Clinical Pharmacology (OCP), Office of Translational Science (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver...

RWE Simulation of Long-term Drug Safety & Efficacy / FDA-CDER-2024-1382

*Applications will be reviewed on a rolling-basis. This project is located in The Office of New Drugs (OND), Immediate Office (IO). This methods study aims to understand if real-world evidence (RWE) can accurately estimate long-term medication safety and effectiveness in a simulated dataset...