FDA issues penalty guidelines for drug inspection delays, obstacles

07/15/2013 | MedPage Today (free registration)

Draft guidance on penalties for drugmakers who deny access to inspectors and delay inspections was released Friday by the FDA. The draft relies on powers obtained from the FDA Safety and Innovation Act, which aims to guarantee the authenticity, proper shipping and distribution of drug products. The guidance defines various circumstances and actions that the agency will consider to be delaying, denying access or limiting inspections.

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