An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

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

Elektra Papadopoulos, M.D., MPH

Updated: Clinical Outcome Assessment (COA) Compendium

Encouraging the use of patient-focused COAs in clinical trials

Learn more

Sub-Topic Paragraphs

Spotlight on CDER Science

Spotlight on CDER Science

Reports on new scientific advances with wide appeal

CDER Conversations Drupal 1600 x 900

CDER Conversations

Timely interviews with CDER's scientific leaders on critical drug-related issues

White text that reads "Regulatory Science Impact Story" on blue background

Impact Stories

Stories illustrating how regulatory science impacts the lives and health of people

Dr. Kathryn Aikin

CDER Scientists in their own words

Video discussions of how current challenges in regulatory science are being met

CDER Director Dr. Janet Woodcock

Dr. Woodcock on Regulatory Science

Educational videos on select regulatory science topics by CDER Director Janet Woodcock

FDA Voices

Views on medical products, policy, and consumer safety from FDA experts

Person writing on a scientific manuscript article with a pen

In Press

A searchable repository of scientific publications by FDA staff

Calendar on a tablet showing meetings and events

Meetings and Events

Upcoming events, past meetings, meeting materials, and meeting transcripts

Stacked manila folders containing reports

Annual Reports

Progress reports on regulatory science from CDER offices, divisions, and programs

Torn paper revealing text that reads What's New

What's New in Regulatory Science

A newsletter on regulatory science for CDER's stakeholders

Top