FDA Clarifies Communication Rules For Medical Product Cos.

By Kellie Combs, Albert Cacozza, Gregory Levine, Douglas Hallward-Driemeier and Emerson Siegle (June 21, 2018, 4:06 PM EDT) -- On June 12, 2018, the U.S. Food and Drug Administration issued two key documents outlining the agency's current thinking regarding drug and device manufacturers' communication of information not contained in product labeling. In particular, the FDA issued final guidance documents laying out the agency's position with respect to (1) manufacturer communications with payors, formulary committees and similar entities, and (2) manufacturer communications consistent with FDA-required labeling. These guidance documents are the final versions of draft guidance documents issued on Jan. 18, 2017. The changes to the guidance documents are extensive, but generally provide additional flexibility for manufacturers to convey certain types of product information....

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