 |
|
New Requirement for Patient Labeling for Selected Prescription Drug Products
JAMA. 1999;281:27.
|
|
| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
|
|
|
The FDA has issued a final rule establishing requirements for the distribution of patient labeling for selected prescription drug and biological products used primarily on an outpatient basis. The agency is requiring the distribution of patient labeling, called Medication Guides, for a small number of products that the agency believes pose a serious and significant public health concern necessitating this distribution. The agency will require Medication Guides if one or more of the following circumstances exists: (1) the product is one for which labeling could help prevent serious adverse effects or (2) the product has serious risks that could affect patients' decision to use, or to continue to use, the product or (3) the product is important to health and patient adherence to directions for use is crucial to the drug's effectiveness.
The FDA anticipates that, on average, no more than five to 10 products per year would require such . . . [Full Text of this Article]
|
