The National Institutes of Health has released a proposed rule designed to provide clarity on the requirements surrounding the submission of information to ClinicalTrials.gov, as mandated by the Food and Drug Administration Amendments Act of 2007. Among these requirements is the submission of summary results for clinical trials involving all pharmaceuticals, medical devices and biological products, regardless of whether they have been approved, licensed or cleared by the Food and Drug Administration. The rule also provides timetable restrictions for the registration of a clinical trial and submission of summary results, as well as guidelines for the reporting of adverse events.… Continue Reading
FDA has released a proposed rule that would amend the regulations affecting direct-to-consumer ("DTC") advertisement regulations to implement a provision of the Food and Drug Administration Amendments Act of 2007. The change in regulations would require DTC television or broadcast advertisements of prescription drugs to place the "major statement" in a "clear, conspicuous and neutral manner." Under the regulation, FDA would use the following standards to determine whether the information meetings the clear, conspicuous and neutral requirement: 1) information is presented in language that is readily understandable by consumers; 2) audio information is understandable in terms of the volume, articulation, and pacing used; 3) textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and 4) the advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.
To learn more about FDA's proposed rule on DTC advertising, please read our full alert.… Continue Reading