FDA to systemize manufacturing standards for combination products

09/27/2009 | Clinica (subscription required)

The FDA has proposed streamlining the current good manufacturing practice standards for combination products in order to prevent the "inconsistent or differing application" of such requirements that "could affect product safety and the public health." The agency also proposed creating a "transparent and streamlined" scheme that can be used by makers of "single-entity" and "co-packaged" combination products when complying with the cGMP requirements.

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