BIO Professional Development
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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
Do we correct information about our drug in a company’s sponsored chat room? What types of websites shouldn’t we link to? Learn the FDA regs and more.
Under what conditions can companies find a safe harbor for communicating investigational data? How and why is scientific exchange codified in the Code of Federal Regulations (CFR). Learn the FDA regs and more.
What are considered good publication practices for communicating company-sponsored medical research and how do these practices impact publication development and planning? Learn more in this pub planning module.
How should reprints with off-label information be issued once they have appeared in peer-reviewed medical journals? Learn the FDA regs and more?
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