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

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 5 days 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 Over the Counter (OTC) Drug Product Regulatory Analysis of Microbial Risks: Case Study on Ophthalmic Eye Drops

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 5 days ago

ability to protect public health by supporting evidence-based approaches to ensure safety through improved labeling and/or packaging recommendations that reduces consumer misuse and prevents infections

FDA Risk Assessment of Contaminants for Supply Chain Risks

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 5 days ago

focusing on injection, otic, and ophthalmic drug products.  You will gain experience evaluating the safety and manufacturing considerations of generic drug products approved in multiple jurisdictions 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 | 5 days 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

Comparing Neonatal Adverse Drug Events from the Literature with FDA Labels

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 5 days ago

the Pediatric Research Equity Act, exceedingly few drug development programs include neonates. As a result, a relatively small number of drugs have the safety and efficacy data necessary to support

FDA Clinical Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 5 days ago

, the participant will collaborate with mentors to investigate critical questions spanning three interconnected research areas: translational safety biomarkers and clinical trial methodologies, emerging substances

FDA Postdoctoral Fellowship in the Application of Microphysiological Systems to Study the Blood-Milk Barrier

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 5 days ago

drug exposure and contribute to the FDA’s ongoing efforts to ensure the safety of medications used during lactation. Learning Objectives: Under the guidance of the mentor, you will receive structured

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 5 days 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 Application of Quantitative Approaches to Streamline Drug Development and Enhance Patient Care

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 5 days ago

oncology and inflammatory & immune diseases, and to support risk and safety evaluation, to identify endpoints for Type 1 Diabetes. During the appointment, you will use the clinical trial data under NDA and

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 5 days 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