BioCentury
ARTICLE | Regulation

Language about language

July 24, 1995 7:00 AM UTC

Statutory and regulatory language that the Center for Biologics Evaluation and Research uses as the basis for its regulation of "labeling", which includes press releases. In particular, according to William Purvis of CBER, the language establishes that communications about a product must be "balanced" to avoid being false or misleading.

SEC. 502. [352] A drug or device shall be deemed to be misbranded - (a) If its labeling is false or misleading in any particular...