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AdvaMed asked the FDA for more examples of combination product types and manufacturing processes for which good manufacturing practices diverge from standard combination product CGMPs. Read More
Manufacturers receiving a heparin sodium drug substance or API represented as “USP” for use in a combination product should document that the substance has been tested according to the current USP drug substance monograph, the agency said. Read More
The agency plans on working with the International Medical Device Regulators Forum on a standard format to support electronic device submissions. Read More