Читать книгу Food Regulation - Neal D. Fortin - Страница 303

Under section 502(f)(1) of the FD&C Act, FDA requires drugs to have adequate directions for safe and effective use.⁷⁴ Many medical conditions are not amenable to self‐diagnosis and treatment by individuals who are not medical practitioners. For example, cancer may require advanced technology using radiological imaging and blood analysis that require a trained medical practitioner for diagnosis and treatment. Therefore, FDA may determine that adequate directions for use cannot be written for some therapeutic claims on a product such that a layperson can use the drug safely for its intended purposes.