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New FDA draft guidance on Contract Manufacturing Quality Agreements

03 June 2013

Pharmaceuticals and Biotechnology Alert

On 28 May 2013, FDA issued a draft guidance for the industry, titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. The release of this draft guidance is important because, although it has long been common practice for drug companies to contract with third parties to perform parts of the manufacturing process (such as formulation, analytical testing, packaging, and labeling) or in some cases, to perform all of the manufacturing process, FDA previously had provided only limited guidance on the issues that the agreements establishing these arrangements should address.

Read more: New FDA draft guidance on Contract Manufacturing Quality Agreements

The team

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