67 machine-learning "https:" "https:" "https:" "https:" "https:" "https:" "https:" "UCL" "UCL" "UCL" positions at Center for Drug Evaluation and Research (CDER)

FDA Drug Product Quality Assessment

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 10 hours ago

to identify where to direct surveillance efforts. Learning Objectives: Under the guidance of the mentor, you will gain knowledge on the development of an analytical method based upon multiple standards

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 10 hours ago

to identify key physiological parameters responsible for altering the PK of LAI in pregnancy and lactation. Learning Objectives: Under the guidance of the mentor(s), the participant will develop the following

FDA Fellowship - Assessing Rare Safety Signals in Psychiatric Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 11 hours ago

(DP) plans to re-evaluate these rare safety signals and to determine whether additional regulatory actions are needed. Learning Objectives: Under the guidance of a mentor, you will have the following

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 10 hours ago

), and therapeutic dose selection for IBD. Identify best practices and gaps in dose-selection methodologies to support regulatory decision-making and future pediatric drug development strategies. Learning

FDA Research Fellowship: Neurodevelopmental Assessment of Prenatal Analgesic Exposure Using Translational Models

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 10 hours ago

dissemination. The participant will regularly present and discuss findings at internal meetings that will include members of NCTR and CDER staff. Learning Objectives: As a participant, you will learn numerous

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

Center for Drug Evaluation and Research (CDER) | United States | 13 days ago

. Learning Objectives: Under the guidance of the mentor, you will gain comprehensive experience in regulatory biostatistics through hands-on analysis of clinical trial data from FDA submissions in

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours ago

will advance FDA's regulatory science mission and public health objectives while promoting the 3Rs principles (replacement, reduction, and refinement) of animal use during drug development. Learning

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 11 hours ago

product testing requirements. Learning Objectives: Educational and Training Components: You will receive multidisciplinary training in: Regulatory science methods: Understanding how final formulation test

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 | about 11 hours ago

to integrate findings into regulatory science discussions. Learning Objectives: You will receive multidisciplinary training in: Regulatory science methods: Understanding how microbial risk assessment informs OTC

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 | about 11 hours 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