Week 4-Part 1

Regulation of Advertising & Promotion Week 4 1
Class Four Introduction: Fair Balanced and Other Material Facts Presentation of Risk Information Content of Risk Information Non-Print Promotion Other Types of Material Facts 2
Introduction Fair Balance : FDA requires manufactures to prominently communicate risks of the drug in a way that is comparable in scope, depth and detail to communication of benefits In 2009- FDA issued Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion FDA regulations provide some examples of "lacking in fair balance"—but the 2009 draft guidance is a guide to OPDP's expectation on this topic 3
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