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New Draft Guidance On Quality Agreements: No Passing The Buck On CGMPs

2013-09-12 09:44:31| drugdiscoveryonline News Articles

Last month, FDA released a draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with manufacturing activities in a manner that is consistent with regulatory requirements. By Cathy L. Burgess, Donald E. Segal and Guillermo Cuevas, Alston & Bird LLP

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Category:Biotechnology and Pharmaceuticals

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