FDA Creates Division To Support First Amendment Policy Development, Oversee Advertising Research
Multiple unfavorable court decisions have forced the agency to adjust its advertising enforcement strategies.
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Office of Prescription Drug Promotion issued six enforcement letters and launched three research projects in 2021. There were more internal changes as the office switched to electronic submissions of promotional materials and went through year-end reorganization.
A growing focus on real-world evidence and an expected infusion of user fee funding are among the reasons for the new office branches at US FDA’s biologics center.
Woodcock’s willingness to stay on at US FDA for more than a transitional period after Robert Califf’s expected confirmation as commissioner may depend on exactly the type of authority and tasks he’d be willing to delegate to her. Plus, some other agency personnel updates.