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FDA REGULATIONS AND GUIDANCE ON
INDUSTRY-SUPPORTED SCIENTIFIC AND
EDUCATIONAL ACTIVITIES
Regulations guiding the conduct of
industry supported scientific and educational activities come under the
purview of the Food and Drug Administration, an agency in the Department
of Health and Human Services. It is extremely important that all
organizations conducting educational activities supported by
pharmaceutical companies and medical device manufacturers be aware of
the particular constraints imposed on industry supported activities.
These regulations apply regardless of whether continuing medical education
(CME) credits will be given for attendance.
The pertinent regulations are found in
the Federal Register dated December 3, 1997 (Volume 62, Number 232),
page 64073-64100. The document is called Final Guidance on
Industry-Supported Scientific and Educational Activities.
It can be found on GPO Access at: www.access.gpo.gov
On the GPO page, select GPO Access.
Under "Quick Links," select Federal Register.
Scroll down to Federal Register Volume and select 1997
Federal Register.
Under Federal Register Sections, select Notices
In Issue Date, enter ON 12/03/1997
In Search Terms, enter: Final Guidance on Industry-Supported
Scientific and Educational Activities
Hit Submit and you will be presented with links to the document
in text, PDF and summary formats.
A useful summary of the content of the
final guidance can be found at:
http://www.fda.gov/cder/guidance/isse.htm |
