FDA Scrutiny of Promotion and Advertising Practices: 2-Day In-Person Seminar by Ex-FDA Official

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.

Learning Objective:

Learn how FDA faces constitutional constraints on enforcement decisions

Learn about intersecting federal requirements by the Department of Justice, the Federal Trade Commission, the Securities and Exchange Commission and the Consumer Product Safety Commission

Learn how the FDA interprets advertising and promotion in principle and in fact

Understand ways that a firm violates FDA requirements

Evaluate advertising and promotional material based on interactive group hypotheticals

Who will Benefit:

Sales and Marketing executives and managers

Regulatory Managers

In-house Legal Counsel and Contract Specialists

3rtd party consultants

Venture Capitalists

Investors

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-scrutiny-promotion-advertising-practices-ftc-mass-media-doj-off-label-seminar-training-80273SEM-prdsm?channel=sciencedz