FDA issues 2 new guidances on medical products

U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf announced that the agency has issued two new draft guidances about medical product communications.

The first guidance, "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities," outlines the FDA's recommendations for communicating healthcare economic information regarding drugs approved under the Federal Food, Drug, and Cosmetic Act (FD&C), which was recently amended by the 21st Century Cures Act.

The second guidance, "Medical Product Communications That Are Consistent With the FDA-Required Labeling," explains the FDA's position on medical product communications that include information not provided in a product's FDA-required labeling but which applies to the approved or cleared uses of the product.

Both are open for public comment through April 19.

In addition, the FDA is inviting feedback regarding communications about unapproved uses of cleared medical products; it has published a document titled "Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products." The agency is also taking comments about this issue through April 19.

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