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FDA Proposes cGMPs for Combination Products

09/23/2009

Federal Register Proposed rule: FDA proposes to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule intends to clarify which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. It also establishes a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for “single-entity” and “co-packaged” combination products. To view this proposed rule, click here.

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