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Drug Industry Daily
Oct. 3, 2012 | Vol. 11 No. 194
FDA Lays Out Requirements for Initial Assessments of DMFs Under GDUFA
The FDA has outlined its checklist of requirements that drugmakers submitting Type II active pharmaceutical ingredient (API) drug master files (DMF) must meet before the files are listed on the agency’s public website as available for reference to support an ANDA.
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