35 evolution "https:" "https:" "https:" "https:" "ESPCI Paris PSL" Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Clinical Pharmacology Considerations for Novel Therapeutic Modalities

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

to their novelty and rapid evolution. The research aims to facilitate product development, assist review decision-making, identify regulatory knowledge gaps, and support evidence-based evaluation approaches

FDA High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 5 hours ago

both the development and regulation of oligonucleotide drugs. Learning Objectives: Under the guidance of the mentor, you will receive instructions on utilizing chromatography, mass spectrometry, and

FDA Regulatory Science Research Project Related to Safety of Medications in Pregnancy in the Post Approval Setting

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

of pregnancy and lactation postmarketing requirement studies. Pregnant and lactating women have historically been excluded from drug development trials. Therefore, at the time of new drug/biologic approval

FDA Application of AI for Precision Medicine Fellowship

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

unstructured submission data for model development; 2) Apply AI methods to identify key clinical and biomarker features that drive response to therapy; 3) Contribute to manuscripts, reports, and presentations

FDA Utilizing Artificial Intelligence to Enhance Pharmacovigilance and Inspection Fellowship

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

the development of innovative AI architectures that graphically interconnect disparate biomedical information sources to address public health needs. Collaborating with interdisciplinary teams to investigate

FDA Modeling and Simulation Fellowships

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

quantitative method support for guidance development, abbreviated new drug application (ANDA) reviews, citizen petitions, controlled correspondence, pre-ANDA meetings, methodology development for bioequivalence

FDA Pharmacy Compounding Regulatory Analysis Fellowship

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

drug compounding, including, but not limited to specific bulk drug substances that are used in compounding, advancing FDA's development of the Bulk Lists of substances that can be used in human

FDA Over the Counter Drug Monograph Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 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 CDER Regulatory Science Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 5 hours 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 Developmental Safety Fellowship

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