October 31, 2013
If you have ever needed to determine whether pulling an FDA-regulated product from retail shelves is a “market withdrawal” or a “recall” you know that the line between these two terms at times is murky at best. So, it is no surprise that there has been some buzz recently about FDA’s October 23, 2013, update to the Agency’s Regulatory Procedures Manual (“RPM”), when FDA stated that “Section 7-5-1, 2(b) ‘Notes,’ was revised to clarify the term ‘market withdrawal.’”
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