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Expert Analysis

How FDA Is Refreshing Its Recall Readiness Guidance

By Greg Levine, Joshua Oyster and Jessica DeLalio (May 29, 2019, 1:12 PM EDT) -- On April 24, 2019, the U.S. Food and Drug Administration released a draft guidance, entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C," to provide additional guidance to industry regarding timely initiation of voluntary recalls of FDA-regulated products. The draft guidance stresses the importance of being "recall ready" and recommends preparations that manufacturers and distributors should take to facilitate timely voluntary recalls....

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