FDA's Promotional Reviews Decline, But Says It's Only Part Of Job
US agency's Office of Prescription Drug Promotion may complete 37% fewer drug promotional material reviews in FY 2017 than previous year.
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Office of Prescription Drug Promotion is focused on most egregious issues where human safety is at stake; CDER's Woodcock also says that First Amendment issues are affecting enforcement.
HHS blog post details activity of US FDA's Office of Prescription Drug Promotion during a year in which the office has only issued one enforcement letter, continuing a downward trend.
OPDP chief Abrams did not give many general tips for complying with guidance on off-label promotion 'consistent with' FDA-approved labeling, leaving sponsors to make own interpretations.