70 computer-security "https:" "https:" "https:" "https:" "https:" "https:" "Dr" "Keele University" positions at Center for Drug Evaluation and Research (CDER)

FDA Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

advanced computational tools under mentorship guidance, and exploring how statistical innovations can enhance regulatory assessments of drug safety and efficacy. Developing expertise in Bayesian hierarchical

Comparing Neonatal Adverse Drug Events from the Literature with FDA Labels

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 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 Fellowship - Development and Validation of AI Prompts to Summarize Industry Submissions

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 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

FDA Fellowship - Enhancing Oncology Dose Optimization Through Patient-Reported Outcome Exposure-Response Analysis

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

detecting safety signals, particularly valuable in early-phase trials with limited sample sizes where critical dose optimization decisions must be made. You will join a project to prospectively assess the use

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

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

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 | 2 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 Clinical Pharmacology / Model Informed Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

are made for nucleotide-based therapeutics—such as antisense oligonucleotides, siRNA, and mRNA—intended for neurological diseases. The you will help investigate how safety margins, nonclinical data

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 | 2 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