50 evolution "https:" "https:" "https:" "https:" "https:" "https:" "ISCTE IUL" positions at Center for Drug Evaluation and Research (CDER)

FDA Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 6 hours ago

documents and to evaluate how dosing strategies are utilized for oncology drugs in pediatric patients. Findings from this project will inform the development of regulatory policy aimed at refining pediatric

FDA Product Specific Guidance and Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

from FDA-funded scientific research can be used to support PSG development. This project includes the development of knowledge management and research management tools to maintain, monitor, and analyze

Comparing Neonatal Adverse Drug Events from the Literature with FDA Labels

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 6 hours ago

therapeutics and generic drugs. This effort covers more than just medicines. Research Project: Despite tremendous strides in pediatric drug development prompted by the Best Pharmaceuticals for Children Act and

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 | about 6 hours 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 Nonclinical Data and Drug Safety Regulatory Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours 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 High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 6 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 Serum Creatinine Elevation Due to Renal Transporter Inhibition

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours 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 Fellowship - Clinical Pharmacology Considerations for Novel Therapeutic Modalities

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 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 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 | about 6 hours 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 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 7 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