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

FDA CDER Regulatory Science Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 15 days ago

for novel drug applications Gain understanding of data pipelines used for dashboard development. Mentor: The mentor for this opportunity is Mary Doi (mary.doi@fda.hhs.gov ). If you have questions about the

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 15 days ago

is applied to Individual Case Safety Reports (ICSRs). They will support the development and refinement of the AI prototype, providing a practical introduction to how AI can be applied to a regulatory

FDA Over the Counter (OTC) Drug Product Regulatory Analysis of Antigingivitis/Antiplaque Monograph

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 15 days ago

role in the development of dental and periodontal diseases. The project’s goal is to provide scientific updates for testing methodology employed to assess the effectiveness of antigingivitis/antiplaque

FDA Clinical Pharmacology of Novel Modality Biological Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 15 days ago

to evaluate innovative study designs for assessing novel modality clinical pharmacology and research regulatory precedents and contribute to guidance document development for emerging therapeutic modalities

FDA Fellowship - Large language Models in Post-Market Surveillance of Drugs Using Social Media

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 15 days ago

to align your interests with areas of research need to OSE (e.g., drug safety, substance use disorders, pharmacovigilance, pharmacoepidemiology methods development). As an OSE-trained fellow, at

FDA Studying the Critical Quality Attributes of Multispecific Antibodies/Fusion Proteins (SARITA 4400)

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 15 days ago

while advancing professional development in antibody therapeutics. Mentor: The mentor for this opportunity is Wen Jin Wu (wen.wu@fda.hhs.gov ). If you have questions about the nature of the research

FDA Fellowship - In Silico and In Vitro Approaches to Inform Polypharmacy and Patient Effects on Opioid Overdose

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 15 days ago

components for each ORISE fellow (computational, complex in vitro modeling - CiVM and bioanalytical). Computational: The participant will assist in the development of quantitative systems pharmacology models

FDA Fellowship - AI to Evaluate Maximum Daily Dose for Topical Drugs

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 15 days ago

setting to conduct clinical trials; and (b) development of AI models for application to regulatory decision making, which is additionally valuable for opening up your future career opportunities. Mentor

FDA Bioequivalence of Complex Generic Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 15 days ago

generic products to support bioequivalence and product development. Learning Objectives: Under the guidance of the mentor, the participant will gain a comprehensive understanding of the scientific and

FDA Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | about 2 months ago

will contribute to developing internal FDA guidance and supporting peer-reviewed publications on appropriate non-inferiority study design and margin justification in modern ophthalmic drug development