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Health and Human Services Department Food and Drug AdministrationFederal RegisterMed source confidence · 76%Jul 1, 2026, 6:34 PM UTC · 6d ago

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products

Case File

The FDA is seeking public comments on a proposed information collection regarding Medication Guides for prescription drug products. This notice is part of the Office of Management and Budget review process. Affected parties include drug manufacturers and healthcare providers. The effective date for this notice is July 1, 2026.

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Why This Matters

Manufacturers of prescription drugs must comply with the new requirements if implemented. They should prepare to adjust their information materials based on the feedback collected.

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