The on-again, off-again efforts of the FDA's office of combination products are back on again. The OCP's good manufacturing practices proposal is intended to clarify confusion surrounding approvals of products that comprise combinations of drugs, biologics and devices. The current work takes the place of stalled draft guidance begun in 2004.
The new proposal distinguishes products that are physically combined during manufacturing to create either single entities or two separate components in the same package (so-called co-packaging) from those that are cross-labeled, in which components are manufactured separately and packaged, but are labeled specifically for use with another product.
The confusion that the FDA is attempting to clarify concerns combinations of products that already have cGMP regulations. Manufacturers sometimes don't understand which of the existing regulations should govern. SmartConsulting Group says the revised regulations will reduce confusion regarding the "which regulations?" question and aid in enforcement consistency. Minimizing paperwork hassles is another objective.
The FDA is in the process of finalizing comments now.
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