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Patient Labeling and Risk
Communication
FDA-Approved Patient Labeling
- Patient Package Inserts.
For some prescription medicines,
FDA approves special patient materials to instruct patients about the safe
use of the product. These materials may be given to patients by their health
care provider or pharmacist, and are considered part of FDA-regulated product
labeling.
- Medication Guides. FDA may require distribution of Medication Guides,
FDA-approved patient information, for selected prescription drugs that pose a
serious and significant public health concern. Medication Guides will be
required if the FDA determines that one or more of the following circumstances
exist:
- patient labeling could help prevent serious adverse effects,
- the drug product has serious risk(s) (relative to benefits) of which
patients should be made aware because information concerning the risk(s)
could affect patients’ decision to use, or to continue to use, the
product;
- the drug product is important to health and patient adherence to
directions for use is crucial to the drug’s effectiveness.
Medication Guides are
available for these products:
*biologic or drug/biologic combination
National Telephone
Surveys of Prescription Medicine Information Received by Consumers
National telephone surveys sponsored by CDER's Division of Drug Marketing,
Advertising, and Communications were conducted in 1992, 1994, 1996, and 1998
to determine how much prescription medicine information consumers receive
and through which sources.
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Office of Drug Safety
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FDA/Center for Drug Evaluation and Research
Last Updated: September 27, 2004
Originator: OTCOM/ODS
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