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quality systems | submissions | guidance documents | good manufacturing practices | FDA | biological product | current good manufacturing practices | combination product | Combination Products

Would you like fries with your Combo meal?

On January 18, 2013, the FDA announced their final rule on current good manufacturing practices for Combination products. These Guidance Documents will tell companies when submissions would be required for any post-approval changes to a combination product. First off, what are Combination products you may ask? It is any combination of a drug, a device, or a biological product. As defined in 21 CFR 3.2, this may refer to two or more regulated components that are physically or chemically combined into a “single” entity, or even a “kit” combination where the before-mentioned are packaged together in a single package. The Combination Products Coalition (CPC) sees this as an excellent move by the FDA, and hopes it will reduce the amount of duplicated work for drug, device, and biological product requirements. But with the new Combination policies, how will this affect current manufacturers? A big long term “pro” might lead to a short term “con” as companies will need to modify their current Quality Systems to accommodate this new rule. Also, what will this do to the number of combination product filings? Will companies take this as a positive, or see it as an additional hurdle? -SJG
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