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U.S. Department of Health and Human Services

Drugs

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Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice Public Hearing

The Food and Drug Administration (FDA) is announcing a public hearing to obtain input from interested persons on FDA's scope and direction in modernizing the regulations, policies, and practices that apply to the conduct of clinical trials of FDA-regulated products. The purpose of this hearing is to solicit public input on FDA’s efforts to modernize the regulatory framework that governs clinical trials and approaches to good clinical practice (GCP), including encouraging the use of innovative models that may enhance the effectiveness and efficiency of the clinical trial enterprise.

Date(s):     April 23, 2012

Note, the second day of the public hearing, April 24, has been canceled.

Time:          8:30 a.m. to 4:30 p.m.

Location:    FDA White Oak Campus
                     10903 New Hampshire Ave
                     Building 31, Room 1503
                     Silver Spring, Maryland 20993

Transcripts of the public hearing and all of the Presentations will be available for review at the Division of Dockets Management and on the Internet at http://www.regulations.gov approximately 30 days after the public hearing.

Webcast of Meeting

For those unable to attend in person, the meeting will also be webcast. Watch the webcast on April 23 from 8:30 am to 4:30 pm. Requirements and instructions for accessing the webcast are below.

You may access the webcast via this link:
https://collaboration.fda.gov/part15hearing/

Webcast Recordings

https://collaboration.fda.gov/p74599499/
https://collaboration.fda.gov/p96362676/
https://collaboration.fda.gov/p72365475/
https://collaboration.fda.gov/p46752914/

Adobe Connect Minimum Requirements:

  • View meetings on Windows, Macs, Unix, and Linux platforms
  • Lan or Broadband internet connection
  • Supports Internet Explorer, Firefox, Safari, Netscape Navigator, AOL
  • Adobe Flash Player (no other downloads needed)
  • VPN and Parachute compatible but not required
  • Test my computer for Adobe Connect-Readiness

Visitor Information

All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1. Please see Directions/Transportation/Parking/Hotels for the FDA White Oak Campus (PDF - 115KB) for directions and further details about transportation and lodging. Map of White Oak Visitor Parking (PDF - 105KB)

Attendance and Registration to Speak

The FDA Conference Center at the White Oak location is a Federal facility with security procedures and limited seating. Attendance is free and will be on a first-come, first-serve basis.

Individuals who wish to attend the public hearing must register by sending an email to ClinTrialPublicMt@fda.hhs.gov on or before April 2, 2012, and provide complete contact information, including name, title, affiliation, address, email, and phone number. Those without email access may register by contacting Jennifer Hymiller. Because seating is limited, FDA may limit the numbers of participants from each organization. Onsite registration on the day of the hearing will be based on space availability on the day of the event starting at 7:30 a.m. If registration reaches maximum capacity, FDA will post a notice closing the meeting registration for the hearing at Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice Public Hearing

Individuals who wish to present at the public hearing must register on or before April 2, 2012, through the email ClinTrialPublicMt@fda.hhs.gov.

If you need special accommodations because of disability, please contact Jennifer Hymiller at least 7 days before the meeting.

For Further Information Contact:

Jennifer Hymiller
Food and Drug Administration
Center for Drug Evaluation and Research
10903 New Hampshire Ave., Bldg. 51, Rm. 6333
Silver Spring, MD 20993-0002
301-796-2147
FAX: 301-847-3529
E-mail: ClinTrialPublicMt@fda.hhs.gov