The QMN Weekly Bulletin
Regulatory Affairs / Commercial Operations

FDA to Require Advance Notice of Possible Manufacturing Stoppages

Nov. 15, 2013
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Certain drug and biologic manufacturers must notify the FDA at least six months before they believe a product may be permanently discontinued or experience an interruption in manufacturing, according to a new proposed rule announced last month. The agency says if six months’ notice is not possible, drugmakers should notify the agency about a potential stoppage “as soon as practicable thereafter, but in no case later than five business days after the permanent discontinuance or interruption in manufacturing occurs.”
Drug GMP Report