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CDER Teleconference:
“An Introduction to the Improved FDA Prescription Drug Labeling”
Tuesday, November 7, 2006
12:30 p.m. – 2:00 p.m. Eastern time
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Handouts and an audio download of this teleconference are available on the ISMP website. To receive an audio CD and handouts by mail, please email dpapubs@fda.hhs.gov.
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Overview
Prescribing information – commonly called the “package insert” – is getting a new look. FDA has revised its rules for the content and format of prescribing information for prescription drug and biological products.
The changes to drug prescribing information are intended to improve patient safety by making it easier for health-care professionals to access, read, and use prescribing information, and increase the extent to which health-care professionals rely on it.
This teleconference will discuss the changes and the role they play in patient safety.
Topics include:
- an overview of prescription drug labeling and related FDA requirements
- the history of the drug labeling initiative
- the implementation schedule for the revised prescription drug labeling
- the major content and format changes to prescription drug labeling and the rationale for the changes
- related FDA electronic labeling initiatives
Moderator: To be announced later.
Introduction by Michael Cohen, R.Ph., M.S., Sc.D, Institute for Safe Medication Practices
Speakers:
Rachel Behrman, M.D., M.P.H., U.S. Food and Drug Administration
Renu Chhabra, Pharm.D., LCDR, USPHS, U.S. Food and Drug Administration
Janelle Derbis, Pharm.D., LCDR, USPHS, U.S. Food and Drug Administration
Brenda Evelyn, SBB (ASCP), U.S. Food and Drug Administration
Mary Kremzner, Pharm.D., CDR, USPHS, U.S. Food and Drug Administration
Theresa Toigo, R.Ph., M.B.A., CAPT, USPHS, U.S. Food and Drug Administration
Fees:
There is no charge for participation in this teleconference.
Accreditation Information:
No continuing education credit will be given for this teleconference.
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Date created: October 24, 2006, updated November 27, 2006 |
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