FDA remains a mysterious in its approach to off-label advertising and promotion. The development of a reasonable and coherent regulatory program seems beyond the FDA’s capacity. What seemed to work in the past does not keep pace with a person’s right to know. That approach runs counter to the FDA’s mantra of “transparency.” Breaking the ice is your job, otherwise, the FDA will freeze you in place. FDA’s regulation of off-label promotion and advertising has kept changing, especially so in the past year.
What FDA says is not acceptable to federal courts. Recent litigation opens the door for new sales and marketing possibilities, but you must use intelligent caution. Otherwise, the FDA may still pounce on you. That’s fine if you want to be the next test case in court. You need to be careful!
Attend this session by expert speaker Casper Uldriks to better understand FDA’s changes and rethinking in its approach to off-label promotion and advertising.
Who Should Attend?
For Pharmaceutical and Medical Device firms:
Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specializes in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He...
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