• New FDA Draft Guidance on Medical Product Communications: What You Need to Know
  • March 2, 2017 | Author: Matthew L. Marshall
  • Law Firm: Morris Polich & Purdy LLP - Los Angeles Office
  • On January 18, 2017, FDA released a Draft Guidance entitled, “Medical Product Communications That Are Consistent With the FDA - Required Labeling - Questions and Answers.” The Draft Guidance provides information for firms about how FDA evaluates their communications regarding medical products, including promotional materials, that present information that is not contained in the FDA - required labeling for the product but that may be consistent with the FDA - required labeling for the product. The following is a summary of what is contained in the Draft Guidance.