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FDA Seeks To Write MedGuides Outside REMS Process

Executive Summary

FDA is searching for a way out of imposing a REMS when only a medication guide is required

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FDA said a Medication Guide need not be encompassed within NPS Pharma’s proposed Risk Evaluation and Mitigation Strategy for teduglutide due to the extensive interactions between short bowel syndrome patients and their health care providers and the inclusion of other patient-directed materials.

FDA MedGuide Distribution Guidance May Mean Little Change For Manufacturers

FDA is demonstrating its intent to use discretion in enforcement with a draft guidance aimed at clarifying when Medication Guides must be distributed. However, as a practical matter, pharmaceutical manufacturers may still have to maintain their existing distribution systems for the guides.

FDA MedGuide Distribution Guidance May Mean Little Change For Manufacturers

FDA is demonstrating its intent to use discretion in enforcement with a draft guidance aimed at clarifying when Medication Guides must be distributed. However, as a practical matter, pharmaceutical manufacturers may still have to maintain their existing distribution systems for the guides.

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