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CDER Live!
Understanding FDA's New Requirements for Prescription Drug Labeling
May 9, 2006, 1 PM to 4 PM EDT

The Food and Drug Administration and the Drug Information Association are co-sponsoring: "CDER Live!: Understanding FDA's New Requirements for Prescription Drug Labeling"

"CDER Live!" will explore the background for revising the content and format of prescription drug labeling and the anticipated improvements in risk communication and management resulting from these new requirements. The panel will offer some guidance for developing and converting labeling, and they will draw on questions presented previously during public meetings to further clarify this important FDA initiative. The panel will also discuss companion initiatives and steps FDA is taking to assist industry in implementing the new labeling requirements.

For more information on the new requirements for physician labeling, please see http://www.fda.gov/cder/regulatory/physLabel/default.htm

This program is free to FDA employees. No registration is required.

When: May 9, 2006
Time: 1 PM to 4 PM EDT

Archived webcast (no password needed)
5/12/2006

 

Meeting Information and Registration [external link]

Moderator:

  • Nancy D. Smith, PhD, Director, Office of Training and Communications, CDER, FDA

Taped Interview with:

  • Janet Woodcock, MD, Deputy Commissioner for Operations, FDA

Guests:

  • Rachel E. Behrman, MD, MPH, Deputy Director, Office of Medical Policy, CDER, FDA
  • Steven K. Galson, MD, Director, CDER, FDA
  • John K. Jenkins, MD, Director, Office of New Drugs, CDER, FDA
  • Janet Norden, MSN, RN, Associate Director for Regulatory Affairs, Office of Medical Policy, CDER, FDA

This program is free to FDA employees. CDER employees may view the program at the following sites:

  • CDER White Oak Building 22, Conf. Rooms 1419, 1421
  • White Oak Building 21, Conf. Room 1539, 2560, 3560
  • CDER Rockwall 2, Conf. Room 7204
  • Montrose Metro Conf. Room B, 4th Floor
  • MPN1 Conf. Room 227
  • Parklawn 13B39
  • The program will also be shown in St. Louis, Conference Room 1006

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Date created: April 7, 2006, updated May 12, 2006

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