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Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Advertising and promotion for devices are weak and lack legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances.
Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of the FDA. The roadblock, however, is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.
FDA's Center for Devices and Radiological Health (CDRH) has never issued comprehensive guidance on advertising and promotion. You are on your own. In contrast, FDA's Center for Drug Evaluation and Research (CDER) uses long-standing regulations and a growing number of guidance documents in its regulatory approach.
Policing social media has become a new regulatory responsibility and FDA is still trying to figure out how to deal with it. Bottom line, do you know when you fail to meet FDA's requirements, or are you guessing? Can you afford to guess? The cost to your business and the confusion left in your customers' minds becomes an unwelcomed nightmare.
Why you should Attend:
In this seminar, you will learn how to navigate FDA's numerous legal options and how to interpret them based on basic legal principles. Applying new guidance documents becomes a new test of the FDA's legal boundaries and enforcement options. The agency is now conducting clinical studies and applying the principles of cognitive psychology to aid in its determination of what a message really conveys.
This academic discipline may or may not get to the root of what consumers take away as the message. Congress and the new FDA Commissioner seem more sympathetic to expanding access to medical treatment before all the conclusive evidence for safety and effectiveness is evaluated by the FDA. Valid off-label information may take the lead in that direction.
This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering, and finance departments. Operating in a stovepipe environment will not work.
You need to understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion practices.
Lecture 1: FDA legal authority
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