FDA Final Rule on Combo Product CGMPs - New!

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Hot off the press!

This final rule clarifies which CGMP requirements apply when drugs, devices, & biological products are combined to create combination products:

Current Good Manufacturing Practice Requirements for Combination Products - A Rule by the Food and Drug Administration on 01/22/2013

In a nutshell:

The FDA is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for "single-entity" and "co-packaged" combination products.

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