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The Food and Drug Administration (FDA) is releasing draft guidance on studying sex differences in the clinical evaluation of medical products. This guidance aims to improve the representation of females in clinical trials and provide recommendations for analyzing sex-specific data. It highlights the importance of understanding different responses to treatments based on sex to improve safety and effectiveness. The public is encouraged to submit comments on this draft guidance by April 7, 2025.

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.