• Embed Doc
  • Copy Link
  • Readcast
  • Collections
  • CommentGo Back
Download
 
 
Guidance for Industry
Presenting Risk Information in
Prescription Drug and Medical
Device Promotion
 DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the
Federal Register 
of the notice announcing the availability of the draftguidance. Submit comments to the Division of Dockets Management (HFA-305), Food and DrugAdministration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should beidentified with the docket number listed in the notice of availability that publishes in the
Federal Register 
.For questions regarding this draft document contact (CDER) Kristin Davis at 301-796-1200,(CBER) Ele Ibarra-Pratt at 301-827-3028, (CVM) Martine Hartogensis at 240-453-6833, or(CDRH) Ann Simoneau at 240-276-0100.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
Center for Devices and Radiological Health (CDRH)
May 2009
 
 
Guidance for Industry
Presenting Risk Information in
Prescription Drug and Medical
Device Promotion
 Additional copies are available from:Office of Communication, Training and 
 Manufacturers Assistance, HFM-40
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852-1448
http://www.fda.gov/cber/guidelines.htm.
(Tel) at 800-835-4709 or 301-827-1800
Office of Training and Communication
 Division of Drug Information, HFD-240
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
 Rockville, MD 20857 
(Tel) 301-827-4573
http://www.fda.gov/cder/guidance/index.htm
Office of Communication, Education and Radiological
Programs
 Division of Small Manufacturers, International and 
Consumer Assistance (HFZ-220)
Center for Devices and Radiological Health
Food and Drug Administration
1350 Piccard Drive
 Rockville, MD 20850-4307 U.S.A.
http://www.fda.gov/cdrh/ggpmain.html
 Email: dsmica@cdrh.fda.gov
Fax: 240.276.3151
(Tel) 800-638-2041 or 240-276-3150
*
Communications Staff, HFV-12
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place,
 Rockville, MD 20855
(Tel) 301-594-1755
http://www.fda.gov/cvm/guidance/guidance.html
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Veterinary Medicine (CVM)
Center for Devices and Radiological Health (CDRH)
May 2009
 
 
Contains Nonbinding Recommendations
 Draft — Not for Implementation
TABLE OF CONTENTSI. INTRODUCTION............................................................................................................................1
II. BACKGROUND............................................................................................................................... 2
A. LEGAL OVERVIEW ...................................................................................................................... 3
B. POLICY OVERVIEW..................................................................................................................... 4
III. FACTORS CONSIDERED IN THE REVIEW OF RISK COMMUNICATION ................... 6
A. GENERAL CONSIDERATIONS .................................................................................................. 7
1. Consistent Use of Language .............................................................................................................. 7 
2. Use of Signals..................................................................................................................................... 7 
3. Framing Risk Information..................................................................................................................8
4. Hierarchy of Risk Information ........................................................................................................... 9
B. CONSIDERATIONS OF CONTENT.......................................................................................... 10
1. Quantity ............................................................................................................................................ 10
2. Materiality and Comprehensiveness................................................................................................ 11
C. CONSIDERATIONS OF FORMAT............................................................................................ 14
1. Print Promotion................................................................................................................................ 15
2. Non-Print Promotion........................................................................................................................ 18
IV. CONCLUSION...............................................................................................................................21
ATTACHMENT: STATUTORY AND REGULATORY REQUIREMENTS FOR LABELING
AND ADVERTISING ................................................................................................................................. 22
of 00

Leave a Comment

You must be to leave a comment.
Submit
Characters: ...
You must be to leave a comment.
Submit
Characters: ...