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FDAnews Drug Daily Bulletin
Nov. 7, 2012 | Vol. 9 No. 219
FDA Lacks Policy to Deal With EU Falsified Medicines Directive, Shortage Concern Looms
The FDA’s lack of a policy or guidance to help API manufacturers deal with a new European directive is causing concern among manufacturers about lost sales and drug shortages in Europe, an expert says. Under the European Commission’s falsified medicines directive, all non-EU API makers must obtain written confirmation from their local regulatory authority to verify that APIs were manufactured according to good manufacturing practices equivalent with those in the EU.
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