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Abstract
The US Food and Drug Administration (FDA) is responsible for regulating the information
on prescription drugs disseminated by sponsors to health care providers and consumers
to ensure that it is truthful and not misleading, and that it presents a fair balance
of benefit and risk information. Thus the public health is both protected and promoted
by the dissemination of honest, accurate information about regulated products. This
paper discusses the regulatory requirements for promotional materials for prescription
drugs and the standards used by the FDA to evaluate these materials. It also discusses
the agency's views on direct-to-consumer advertising, the enforcement actions that
are available to the FDA, the process used by the FDA to determine what action should
be taken and when, and what remedies are available.
Keywords
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References
21 U.S.C. § 352(n).
21 C.F.R. § 202.1(1)(2).
21 C.F.R. § 202.1(1)(1).
21 C.F.R. § 202.1(e)(2).
21 U.S.C. § 321(n).
21 C.F.R. § 202.1(j)(1).
21 C.F.R. § 314.81(b)(3).
21 C.F.R. § 202.1(j)(4).
21 C.F.R. § 201.1(e)(1).
62 FR 43171, August 12, 1997.
21 C.F.R. § 202.1(e)(1).
Article info
Identification
Copyright
© 1998 Published by Elsevier Inc.
