Sponsors soon have a chance to advise the US Food and Drug Administration on the barriers and facilitators to implementing innovative clinical trial designs.
US FDA Solicits Comments On Barriers To Innovative Trial Design Implementation
In admitting problems, the FDA creates a docket for comments and will convene a public workshop in the spring on why the clinical trial innovation is not more widespread.
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Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.
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Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.