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FDA Issues Revised Draft Guidance on Off-Label Communications to Health Care Providers – Expanded Scope, Yet Limitations Remain | Dechert LLP
The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products. The Revised Draft Guidance.
Categories of communications
Communications should not use persuasive marketing techniques
Device manufacturer communications with payors
Drug administration
Communications should be clinically relevant
Revised draft guidance
Medical publications
Unapproved new uses
From firms
Unapproved uses
Cleared medical products
Recommended practices
Federal food
Cosmetic act
Draft guidance
Differences between
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