Wednesday, September 30, 2009

FDA Releases Proposed Guidance On Combination Products

Updated April 25, 2017

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FDA - Combination Products Guidance Documents

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- -  original post follows below  - -

This Federal Register notice announces the FDA release of a proposed rule on combination products, Current Good Manufacturing Practice
Requirements for Combination Products (pdf)
. According to the FDA Law Blog post, FDA Issues Proposed Rule on cGMPs for Combination Products:

The proposed rule does not independently establish new requirements, rather, it clarifies which set of existing cGMP regulatory requirements apply when drugs, devices, and biological products are combined to create a combination product.
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