The FDA has released a final guidance document for industry titled "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers." This guidance outlines the FDA's policy on how companies can share scientific information about unapproved uses of approved medical products with healthcare providers. This communication should be truthful and help healthcare providers understand the information's strengths and weaknesses. The guidance, which will not be implemented until the Office of Management and Budget approves related information collection activities, is designed to ensure that such communications are done in a responsible manner.
Simple Explanation
The FDA has a new set of rules for companies about telling doctors how a medicine could help in different ways not yet approved officially. They're waiting for a green light to use these rules, and they want to make sure that companies share this info clearly and truthfully.