Question
TQ 4.1: What kinds of product conversations are excluded from FDA regulations? Is there any context in which off-label uses may be discussed? What is
TQ 4.1:What kinds of product conversations are excluded from FDA regulations? Is there any context in which off-label uses may be discussed? What is the FDA's articulated justification for the position it takes on the preceding questions? TQ 4.2:May company physicians/researchers address research about the side effects of an off-label use of a company product at a medical conference that qualifies as "independent"? What if the question about the side effects arises in Q&A at the conclusion of a presentation about a company product - how does the FDA classify this "request" and how does the Unsolicited Requests Guidance indicate that it should be handled? TQ 4.3:According to the OIG compliance guidance, how can a pharmaceutical manufacturer ensure that its grant program is not being used to improperly market the company's product? TQ 4.4:A company sales representative wants to take a doctor and his staff out to a quick lunch at Chipotle before making an informational presentation at the doctor's office. Is this allowed under the PhRMA Code? What if the Chipotle is located inside of a hospital? TQ 4.5:"Bona fide" is a term that comes up often in the context of arrangements between pharmaceutical companies and consultants. How would you define this term and when does it apply? TQ 4.6:Describe one key difference and one key similarity between the PhRMA Code and the AdvaMed Code.
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