Federal Register Proposed rule: FDA is proposing to amend its regulations for direct-to-consumer (DTC) advertisements of prescription drugs to implement a new requirement of the FD&C Act that the major statement in DTC television or radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous and neutral manner. The agency is also proposing standards that the agency would consider in determining whether the major statement in these advertisements is presented in the manner required by FDA Amendment Acts. To view this proposed rule, click here.