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Physical-chemical identifiers: a q&a with FDA on the final guidance

FDA published in October 2011 the final guidance, Incorporation of Physical– Chemical Identifiers (PCIDs) into Solid Oral Dosage Form Drug Products for Anticounterfeiting (1). The document was issued as a follow–up to the agency's 2004 Counterfeit Drug Task Force Report to facilitate the use of authentication technologies such as PCIDs, and is meant to provide guidance for industry on how using the technology would change the information expected to be provided in regulatory submission. [more...]

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