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A Look into FDA's New Draft Guidances on Manufacturer Communications

Date: Thursday, October 26, 2017 8:00 AM - Thursday, October 26, 2017 10:00 AM

Venue: The Westin Waltham, Boston, MA

In 2017, the Food and Drug Administration issued two draft guidances for drug and device manufacturers regarding product communications. The first is a long-awaited guidance addressing communications with payors, formulary committees, and similar entities. The second provides information about how companies can communicate information about uses of their products that is consistent with, but not included in, the FDA-approved labeling. Both draft guidances have significant regulatory implications for companies operating in the life sciences industry.

Join lawyers from Covington's leading Life Sciences practice as they discuss the opportunities these draft guidances create for companies, provide insights for implementation, and explore the evolving enforcement landscape. We will provide practical advice for evaluating the risk of current promotional activities and managing compliance programs to avoid future troubles with regulators.

Covington's distinguished panel will include:

  • Stefanie Doebler, Of Counsel, Life Sciences Regulatory and Compliance
  • Michael Labson, Partner, Life Sciences Regulatory and Compliance
  • Mona Patel, Partner, Life Sciences White Collar Defense and Investigations

Registration begins at 8 a.m.
Program from 8:30 a.m. to 10 a.m.

Click here to RSVP

CLE credit is pending