DTC User Fee Program’s Demise Leaves Advertisers Bobbing In Its Wake
Executive Summary
FDA's formal termination of the user fee program for review of direct-to-consumer advertising does not resolve the regulatory uncertainty surrounding the ads. Sponsors are now faced with the prospect of stricter penalties for advertising violations without an expedited means of obtaining immunity from them
You may also be interested in...
DTC Pre-Review Guidance In The Works For Rx TV Ads, FDA’s Abrams Says
Certain drug classes will be required to submit certain types of ads, according to Tom Abrams, director of CDER’s recently elevated Office of Prescription Drug Promotion, but specifics will await the guidance itself.
Industry Missing A Public Health Opening With DTC Ads, FDA’s Hamburg Says
The messages conveyed through pharmaceutical direct-to-consumer advertising, and FDA’s role in regulating such promotions, are ripe for re-examination, Commissioner Margaret Hamburg said July 25.
Industry Missing A Public Health Opening With DTC Ads, FDA’s Hamburg Says
The messages conveyed through pharmaceutical direct-to-consumer advertising, and FDA’s role in regulating such promotions, are ripe for re-examination, Commissioner Margaret Hamburg said July 25.