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In Law360, Life Sciences Attorneys Examine FDA Voluntary Recall Draft Guidance

Practices: Life Sciences, FDA Regulatory, Digital Health

Life sciences partner Greg Levine, life sciences associate Joshua Oyster and corporate associate Jessica DeLalio (all of Washington, D.C.) co-authored a Law360 article published on May 29. The article examines the U.S. Food and Drug Administration draft guidance on voluntary recalls of FDA-regulated products.

The authors note that FDA product manufacturers and distributors should evaluate their existing policies and procedures related to recalls to assess whether there are opportunities for improvement based on the draft guidance, such as implementing enhanced training, performing mock recalls or developing communications templates. However, the guidance does not address some of the most difficult recall-related questions that firms will encounter.

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