Pre-approval Promotion: Corporate Communications May Draw US FDA Scrutiny
Executive Summary
Biopharma sponsors should start with information that needs to be disclosed to satisfy SEC rules and understand how a press release will be used to avoid running afoul of agency regulations, industry exec says; company contracts with investigators also should set limits on what they can say about an unapproved drug.
You may also be interested in...
US FDA Advertising Citations Remain Rare In 2018
With only seven letters last year, Office of Prescription Drug Promotion appears to be continuing its enforcement retrenchment as agency reconsiders its approach to Rx communications.
Advertising Enforcement: US FDA Content To Let Competitors 'Duke It Out,' Woodcock Says
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.
FDA’s Rx Promo Citations Rise Slightly In 2016; Investigational Drug Promos Scrutinized
Office of Prescription Drug Promotion seemed to expand its focus in issuing 11 letters last year.