79 web-developer-"https:"-"https:"-"https:" positions at Center for Drug Evaluation and Research (CDER)

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

concern related to inadequate patient adherence which leads to treatment failures and relapse of chronic disease. Long-acting injectable (LAI) drug products are being developed to overcome inadequate drug

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

developing comprehensive databases to systematically evaluate the current landscape of in vitro data utilization in drug development. This research will contribute to the development of innovative

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 | 12 days ago

trispecific fusion proteins. Using breast and ovarian cancer cell models, you will help develop bioassays to evaluate and improve the quality, safety, and anti-tumor activity of FDA-regulated products. Learning

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 | 12 days ago

(PROs) represent the only quantitative tool available to assess tolerability of oncologic agents under development, providing unique insights into the patient experience of symptomatic adverse events

FDA Bioequivalence of Complex Generic Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

under abbreviated new drug applications (ANDAs) and NDAs. The project will identify and develop in vitro, in vivo, or in silico techniques that may be capable of determining how various complexity factors

FDA High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 12 days 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 Biomarker Analysis: Addressing the Gap Between Patient Enrollment Applications and Pharmacodynamic Effect Evaluation

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

generic drugs. These efforts cover more than just medicines. Research Project: Some biomarkers have been used as multiple roles through one drug development such as a diagnosis biomarker for patient

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

safety evaluators to discuss findings and their implications for regulatory policy development and review practices. Presenting research findings to the Division of Clinical Pharmacology and other

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days 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 Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

validation of human-based in vitro and computational methods submitted to FDA for regulatory use. The developed models will be used to predict various toxicity endpoints and drug exposure to help provide