FDA Regulations For clinical trials
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.
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 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:
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
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.
You might also like
THE NEW York Times, FRIDAY, SEPTEMBER 28, 2007,REPORTS ASSAILS F.D.A. OVERSIGHT OF CLINICAL TRIALS and Various Articles
Book (ARTHUR OCHS SULZBERGER)
BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.