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](https://public4.pagefreezer.com:443/content/FDA/09-10-2023T11:56/https://www.fda.gov/files/styles/medium_3/public/SpotlightCDERScience_Drupal_1600x900_0.png?itok=2mXickgw)
Spotlight on CDER Science:
Pharmacodynamic Biomarkers: Their Role in Biosimilar Product Development
![White text that reads "Regulatory Science Impact Story" on blue background](https://public4.pagefreezer.com:443/content/FDA/09-10-2023T11:56/https://www.fda.gov/files/styles/medium_3/public/Drugs-Img-Regulatory-Science-Research-Standard-Graphic-White-Text-Blue-Background-1600x900.png?itok=azoQshZ_)
Impact story:
New developments in regulatory QSAR modeling: a new QSAR model for predicting blood brain barrier permeability
![CDER Conversations Drupal 1600 x 900](https://public4.pagefreezer.com:443/content/FDA/09-10-2023T11:56/https://www.fda.gov/files/styles/medium_3/public/CDERConversations_Drupal_1600x900.png?itok=_LAk8kua)
CDER Conversations:
Biosimilar User Fee Amendments Latest Implementation: BsUFA III
![What's New?](https://public4.pagefreezer.com:443/content/FDA/09-10-2023T11:56/https://www.fda.gov/files/styles/medium_3/public/CDER-whatsnew.png?itok=fZXimvZa)
What's New in Regulatory Science Spring 2023:
A newsletter featuring new developments and opportunities for stakeholders
![SBIA Chronicles](https://public4.pagefreezer.com:443/content/FDA/09-10-2023T11:56/https://www.fda.gov/files/styles/medium_3/public/SBIAChronicles_1600x900_230509.png?itok=r3kydHtk)
SBIA Chronicles Podcast
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
![OTS Research Report](https://public4.pagefreezer.com:443/content/FDA/09-10-2023T11:56/https://www.fda.gov/files/styles/medium_3/public/OTS_ResearchReports_230509.png?itok=d5G-U-uf)
Research Reports
Division of Applied Regulatory Science 2022 Annual Report