Legislation & Regulation

Discover essential legislative and regulatory resources tailored for managed care pharmacy professionals. Stay informed with the latest updates, policies, and advocacy tools to effectively navigate and influence the health care landscape.

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AMCP Submits Comments to FDA on Final Guidance on Payor-Manufacturer Communications

On July 13, 2018, AMCP provided comments in response to FDA Final Guidance on Payor- Manufacturer communications. AMCP supported the need for timelier and more proactive communications between biopharmaceutical manufacturers and population health decision makers. AMCP applauded the FDA for its leadership and recognition of the importance of modernizing the provisions of the Food and Drug Administration Modernization Act (FDAMA) Section 114 as amended by Section 3037 of the 21st Century Cures Act (Cures) and the creation of a safe harbor for the exchange of preapproval communications.
Legislation & Regulation