Regulatory Science in Action
Developing new tools, standards, and approaches to assess drug safety, efficacy, quality, and performance
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RECENT ADVANCES IN THE SCIENCE OF DRUG DEVELOPMENT AND EVALUATION
Spotlight on CDER Science:
Pharmacodynamic Biomarkers: Their Role in Biosimilar Product Development
Impact story:
New developments in regulatory QSAR modeling: a new QSAR model for predicting blood brain barrier permeability
CDER Conversations:
Biosimilar User Fee Amendments Latest Implementation: BsUFA III
What's New in Regulatory Science Spring 2023:
A newsletter featuring new developments and opportunities for stakeholders
SBIA Chronicles Podcast
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
Research Reports
Division of Applied Regulatory Science 2022 Annual Report