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In this section: Science and Research | Drugs

Regulatory Science in Action

Developing new tools, standards, and approaches to assess drug safety, efficacy, quality, and performance

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Spotlight on CDER Science

Spotlight on CDER Science:

Pharmacodynamic Biomarkers: Their Role in Biosimilar Product Development

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Impact story:

New developments in regulatory QSAR modeling: a new QSAR model for predicting blood brain barrier permeability

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CDER Conversations:

Biosimilar User Fee Amendments Latest Implementation: BsUFA III

What's New?

What's New in Regulatory Science Spring 2023:

A newsletter featuring new developments and opportunities for stakeholders

SBIA Chronicles

SBIA Chronicles Podcast

The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

OTS Research Report

Research Reports

Division of Applied Regulatory Science 2022 Annual Report

Meetings and Events

Upcoming events, past meetings, meeting materials, and transcripts

In Press

Scientific publications by FDA authors

Reports

Progress reports from CDER’s scientific offices.

FDA Grand Rounds

Webcasts highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health.

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