The QMN Weekly Bulletin

FDA to Require Advance Notice of Possible Manufacturing Stoppages

Nov. 15, 2013
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