FDA Standardizes REMS Documents For Certain Fentanyl Products

By The Pink Sheet Daily / Email the Author / “The Pink Sheet” DAILY Jan. 7, 2011
Word Count: 308 / Article # 14110107008

Executive Summary

ProStrakan's Abstral is first use of the REMS templates; the agency expects sponsors of similar immediate-release transmucosal products to follow suit and share a REMS implementation system.

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Subject: FDA Standardizes REMS Documents For Certain Fentanyl Products

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FDA Standardizes REMS Documents For Certain Fentanyl Products

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