“An Introduction to the Improved FDA Prescription Drug Labeling”

 

Co-sponsored by the U.S. Food and Drug Administration and Institute
for Safe Medication Practices

Originally presented on Tuesday, November 7, 2006

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

Introduction: Matthew Grissinger, R.Ph., FASCP, Institute for Safe Medication Practices
Moderator: The 90-minute program was moderated by Theresa Toigo, R.Ph., M.B.A., CAPT, USPHS, U.S. Food and Drug Administration.
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;
• Brenda Evelyn, SBB (ASCP), U.S. Food and Drug Administration;
• Mary Kremzner, Pharm.D., CDR, USPHS, U.S. Food and Drug Administration; and
• Elizabeth Sadove, Regulatory Counsel, U.S. Food and Drug Administration.

Fees:

There is no charge for the presentation or audio recording.

Materials:

It is recommended that the material is downloaded, saved locally to your computer, printed, and used by participants in order to follow along with the speaker.  It would be beneficial for participants to review this before the program begins.For your convenience and for referral by speakers during the program, each slide is numbered.

The presentation file for this conference is available on our web site (click here to view it).

In addition, the audio portion of the teleconference can be found here.  

This is not a web conference so you will have to manually move from slide to slide to follow along with the speakers.

If you are unable to click on this link to download, copy and paste the URL http://www.ismp.org/fda/download.asp into your web browser (i.e., Microsoft Explorer) to download the audio file.  The slide presentation and handouts are available only as Adobe Acrobat PDF files. 

If you do not have Adobe Reader you can download it at http://www.adobe.com/products/acrobat/readstep2.html or it can be obtained from the teleconference download page on our web site.

Accreditation Information:

No continuing education credit is available for this teleconference. However, FDA is developing an online CE course that will be available in the near future. For more information on prescription drug labeling, please visit the following websites:

• New Requirements for Prescribing Information http://www.fda.gov/cder/regulatory/physLabel/
• Patient Safety News http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=56#7