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FDA Unapproved Drug Draft Compliance Policy Allows One-Year Grace Period

This article was originally published in The Tan Sheet

Executive Summary

FDA intends to permit a one-year grace period before taking enforcement action against firms marketing unapproved drugs following the approval of a drug of the same type under a new drug application, according to a draft 1compliance policy guide published in the Oct. 23 Federal Register

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FDA Employs Carrot, Stick Under Unapproved Drug Enforcement Strategy

Unapproved drugs that "present direct challenges" to FDA's new drug approval and OTC drug monograph systems will be high priority for enforcement actions, according to an agency guidance released June 8

FDA Employs Carrot, Stick Under Unapproved Drug Enforcement Strategy

Unapproved drugs that "present direct challenges" to FDA's new drug approval and OTC drug monograph systems will be high priority for enforcement actions, according to an agency guidance released June 8

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