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For the first time, FDA officials can detain drug products they believe are adulterated or misbranded. They can detain the drug for up to 20 days, and a drug importer has just 5 days to appeal the detention order after receiving it.

Plus, FDASIA allows the agency to register importers and directs it to establish Good Importer Practice (GIP) regulations.

We’ve invited John Taylor III, Counselor to the Commissioner and Acting Deputy Commissioner for Global Regulatory Operations and Policy at FDA to provide details.

The last few months have seen a sharp increase in FDA’s enforcement powers: the ability to detain drug products at the border, allowing investigators to take photos in your facility without your approval and new registration requirements.

Coupled with increasingly LONG and very DETAILED Form 483s and Warning Letters, it’s enough to make any quality or compliance professional a little nervous.

Today’s inspectors are a breed unto themselves — many have worked in industry and know where traps are hiding in your plant or its documentation. They are highly educated, clear-headed and are well trained to look into every aspect of your operations.

Take a rare opportunity to pick FDA investigators’ brains – how they think and what they look for. Learn secrets of proving your outsourcing oversight works. Find out what’s just down the FDASIA pike. Take a sneak peek below at top-notch speakers.