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.
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PhRMA’s assistant general counsel says that FDA’s draft might increase expenses because of the need to submit final ads in advance and the potential to be asked for extensive revisions.
The agency’s draft guidance on prereview of television advertisements also requires companies to submit the information they rely on to support claims in an ad.
Since releasing its annual guidance agenda in December, FDA has added a number of guidances to its development agenda.