If you go 'off label' with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments need to collaborate now more than ever before. Firms need to identify practical criteria to make marketing decisions. The big question is whether or not marketing managers and regulatory affairs managers will really try to reach common ground. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. 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. Bottom line, do you know when you are running afoul of FDA's requirements or are you guessing? Can you afford to guess? The cost to your business and the confusion left in your customer's mind becomes an unwelcomed nightmare.
With 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 now applies 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. What is more challenging is whether a consumer's mind makes its decisions on what it learns versus pre-existing emotional factors that may or may not be conscious.
Who will Benefit:
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