This year, as the FDA begins to implement its new computerized import-screening tool called PREDICT, drug- and devicemakers are warily anticipating how it will affect the entry of their products into the U.S.
Clearly, some manufacturers will benefit by getting expedited releases ... but others will face dramatic slowdowns.
Now you can learn the ins and outs of how the new FDA processes will work, so you can be better prepared to pass through customs — without holds or inspection.
This management report is designed to address your specific concerns about PREDICT and the new FDA import processes — and show you how to prepare to successfully get your imported products through customs as quickly as possible.
Here’s just a sample of what you’ll learn about the key issues:
You’ll also get answers from a leading expert to some of the most frequently asked questions from industry about imports:
Finally, FDA Import Holds gives you actual “working tools” — model documents to help you better understand how the FDA approaches import investigations, including:
No importing company can avoid an FDA import inspection or a screening that could lead to closer inspection or sampling. But every savvy drug- and devicemaker can — and should — understand the FDA’s processes and how they are changing as PREDICT takes hold.Don’t expose your company to unnecessary holds, impoundments, warning letters — or worse.
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