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  1. News & Events for Human Drugs

How to Navigate CDER Workshops for Advocacy Groups

CDER and You: Keys to Effective Engagement

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) conducted a public workshop entitled “CDER and You: Keys to Effective Engagement.” This marked the third annual CDER public workshop for patient advocacy groups. It built upon previous efforts to help advocates understand how they can engage with the FDA to enhance drug development and safety.

DATE, TIME, AND LOCATION

April 3, 2018, from 9 a.m. to 3 p.m.

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 (The Great Room A, B, and C)
Silver Spring, MD, 20993

Meeting Agenda

Meeting Materials

Links to CDER and You: Keys to Effective Engagement Public Workshop held on April 3, 2018

 


 

Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), sponsored a public workshop entitled “Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research.” The purpose of this public workshop was to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER.

DATE, TIME AND LOCATION

May 12, 2017, from 9 a.m. to 3 p.m 

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 (The Great Room A, B, and C)
Silver Spring, MD, 20993

Meeting Agenda

Meeting Materials

Links to Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research held on May 12, 2017

FOR FURTHER INFORMATION CONTACT
CONTACT:
NAV-CDER@fda.hhs.gov.
TRANSCRIPTS
A transcript of the workshop will be available for review at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and on the Internet at http://www.regulations.gov approximately 30 days after the workshop. Transcripts will also be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency’s Web site at http://www.fda.gov.
 

 


 

Navigating CDER: What You Should Know for Effective Engagement 

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), sponsored a public workshop entitled “Navigating CDER: What You Should Know for Effective Engagement.” The purpose of this public workshop was to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER.

FDA Voice Blog: A 'Roadmap' for Navigating Patient Advocacy 

DATE, TIME AND LOCATION

March 31, 2016, from 8:30 a.m. to 5 p.m. FDA White Oak Campus

10903 New Hampshire Avenue
The Great Room (Room A, B and C)
Silver Spring, MD, 20993

Agenda (PDF - 41KB)

Navigating CDER Transcript from March 31, 2016 Workshop (PDF - 718KB)

Meeting Materials

FDA Campus Information

Links to Navigating CDER Workshop held on March 31st

FOR FURTHER INFORMATION CONTACT

CONTACT: NAV-CDER@fda.hhs.gov.

TRANSCRIPTS

A transcript of the workshop will be available for review at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852, and on the Internet at http://www.regulations.gov approximately 30 days after the workshop.  Transcripts will also be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request.  The Freedom of Information office address is available on the Agency’s Web site at http://www.fda.gov.

 
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