New Guidances on Medical Product Communication and Multiple Endpoints in Clinical Trials

1. FDA announces new draft guidances on medical product communication

FDA announced the release of two guidances related to medical product communications and reopened the comment period for the off-label Public Hearing.
For more information about this release, please see the Statement from FDA Commissioner Robert Califf, M.D.

The guidances and information on the comment period for the off-label public hearing can be found at: 

Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers

Medical Product Communications that are Consistent with the FDA-required Labeling – Questions and Answers

Reopening Public Comment Period for Part 15 Hearing on Manufacturer Communications About Unapproved Uses of Approved/Cleared Medical Products

2. Multiple Endpoints in Clinical Trials; Draft Guidance for Industry

This guidance provides sponsors and review staff with the Agency’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products.