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U.S. Regulatory Environment
Overview of the government agencies/trade organizations that “regulate” drug and medical device promotion: FDA; OIG; PhRMA; AMA; and ACCME.
Takeaways
- There are specific government agencies and trade organizations responsible for drug and medical device promotion
- The Food Drug Administration (FDA), Office of Inspector General (OIG), Pharmaceutical Research and Manufacturers of America (PhRMA), American Medical Association (AMA), and Accreditation Council for Continuing Medical Education (ACCME) each play a distinct role
- It’s important to understand these groups’ policies, guidances, and codes
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