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PhRMA Wants MedGuides Developed The Pre-FDAAA Way, Not Through REMS

This article was originally published in The Pink Sheet Daily

Executive Summary

Using 1998 authority would reduce the burden on sponsors, physicians and patients, industry group says.

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Eliminating MedGuide-Only REMS Merits PDUFA-Style Deadlines, PhRMA Says

FDA should take no more than three months deciding whether a Medication Guide can be pulled out of an existing Risk Evaluation and Mitigation Strategy, the Pharmaceutical Research and Manufacturers of America believes.

Eliminating MedGuide-Only REMS Merits PDUFA-Style Deadlines, PhRMA Says

FDA should take no more than three months deciding whether a Medication Guide can be pulled out of an existing Risk Evaluation and Mitigation Strategy, the Pharmaceutical Research and Manufacturers of America believes.

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FDA is demonstrating its intent to use discretion in enforcement with a draft guidance aimed at clarifying when Medication Guides must be distributed.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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