www.fdanews.com/articles/159846-fda-to-require-advanced-notice-of-potential-manufacturing-stoppages
FDA to Require Advanced Notice of Potential Manufacturing Stoppages
November 4, 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 published Thursday. 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 Industry Daily
Drug Industry Daily