consistent with changes described in FDA memos of 11-21- 01,
11-28-01 and 12-3-01. FDA shall conduct a study of nonres- pondents
to the patient survey to assess the representativeness of the
sample in this survey. Approval is for 18 months which will give
FDA sufficient time to complete this collection.
Inventory as of this Action
The FDA is required under Food, Drug,
and Cosmetic Drug, and Cosmetic Act to assure that the advertising
of prescription drugs is truthful and not misleading. Under a final
August 1999 guidance, manufacturers were instructed how to
construct television and radio ads that were consistent with the
regulations by disclosing both the benefits and the major risks of
the prescription drug being advertised. At the time, FDA stated it
would assess the effects of the guidance, and of the agency's DTC
policies in general, within the subsequent two years. A number of
DTC promotion increase the studies,........