56 evolution "https:" "https:" "https:" "https:" "https:" "https:" "Babes Bolyai University" positions at Center for Drug Evaluation and Research (CDER)

FDA Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours ago

generic drugs. This effort covers more than just medicines. Research Project: With the development of Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance, the Office of Quality

FDA Over the Counter Drug Monograph Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours ago

, or sunscreens to support monograph development and updates. Participants will engage in learning opportunities through mentored training sessions focused on OTC drug monograph research methodologies and

FDA Evaluating the Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours ago

to drugs in the breastfed infant. This project focuses on development of PBPK models for LAI drug products (e.g., antiretroviral drugs and psychiatric drug products). The anticipated project outcomes

FDA Research Opportunity - Analysis of Patient Diversity and Ineligibility Rates in Cancer Pivotal Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 17 hours ago

presentations, and gain experience in addressing health equity issues in drug development. You will develop skills in analyzing clinical trial diversity, understanding regulatory requirements for demographic

FDA Regulatory Analysis of Dose-Finding and Optimization Approaches in Targeted Oncology Therapeutics

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 17 hours ago

clinical data from multiple sources within FDA's information systems. You will gain regulatory science experience and policy development insight that supports advancement in clinical pharmacology, drug

FDA Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 17 hours ago

development for inflammatory bowel disease (IBD). Since the approval of infliximab for Crohn’s disease in 1998, multiple advanced therapies—including ten biologics and four small molecules—have been approved

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours ago

development have been restricted to juvenile animal studies for the past 20 years. The FDA program to reduce, refine and replace animal studies has stimulated an important discussion about both increasing

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 | about 17 hours 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 Large Language Models (LLM) for Case Definition Classification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours 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 | about 17 hours 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