Written
by Frank Baker ©2004
Ad rules from the FDA
website
Q. What must a prescription drug advertisement include?
Under section 502(n) of the FD&C Act, advertisements
must include: the established name, the brand name (if any), the
formula showing quantitatively each ingredient, and
information in brief summary which discusses side effects, contraindications,
and effectiveness. The brief summary is further discussed in 21
CFR 202.1(e)(1).
Q. Are there exceptions to the advertising regulations?
Reminder advertisements - advertisements which call
attention to the name of the drug product but do not include
indications or dosage recommendations for use of the
product, or any other representation. Reminder ads contain the proprietary
name of the drug and the established name of each active
ingredient. They may also contain additional limited
information, such as the name of the company, price, or dosage
form.
What
you should know: Prescription Drug Ads
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