Drugs

CDER and You: Keys to Effective Engagement

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

CDER seeks to share information on navigating CDER’s engagement resources with stakeholders including patients, patient advocates, academic and medical researchers, health care professionals, drug developers, and others.

The workshop equips stakeholders with knowledge they need to share their unique perspectives on drug development and safety. It will include educational presentations about the drug approval process, an interactive panel featuring patient advocates who will offer guidance on engaging with CDER, as well as an opportunity for questions and answers following many of the presentations. Finally, presenters will explain CDER’s new procedure for requesting drug-related meetings.

This website will be updated as workshop materials are developed. Please monitor the Federal Register and the Professional Affairs and Stakeholder Engagement (PASE) web page for additional information on this public workshop.


MEETING AGENDA:

DATE:

Tuesday, April 3, 2018

TIME:

9 a.m. – 3 p.m.

LOCATION:

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503 (Great Room – A, B, and C)
Silver Spring, MD, 20993

REGISTRATION:

Persons interested in attending this workshop in person or via webcast must register online at FDA Public Workshop – CDER and You: Keys to Effective Engagement.

Online registration closes at 6 p.m. EST, Tuesday, March 20, 2018. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Onsite registration on the day of the public workshop will be provided beginning at 8 a.m. Registration is free and will be on a first-come, first-served basis. Early registration is recommended. If you need special accommodations due to a disability, please contact Chris Melton no later than March 26, 2018 at 301-796-7381 or NAV-CDER@fda.hhs.gov.

Attend via webcast: https://collaboration.fda.gov/cdereffectiveengagement/

TRANSCRIPTS:

Please be advised that as soon as a transcript of the public workshop is available, it will be assessable at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 1061, Rockville, MD  20852, approximately 30 days after the workshop. Transcripts will also be available, 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/RegulatoryInformation/FOI/default.htm.

For parking and security information, please refer to the following link:  
Public Meetings at the FDA White Oak Campus

FOR FURTHER INFORMATION, CONTACT: 

NAV-CDER@fda.hhs.gov

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