FDA, is That Your “Final Answer?” Never Say Never When it Comes to Reversing FDA Import Refusals
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May 02, 2012
Company News, Drugs, Imports, Law & Regulatory
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Tags: compliance officers, detainment, drugs, FDA, final rule, importers, medicine, misbranded, refusal, regulation
If you remember only one thing about FDA-related legal matters involving imported products it should be this: Even if FDA issues a “final” FDA refusal on a legal matter, it is still possible to 1) prove that the FDA got it wrong, and 2) convince FDA to reverse itself.
For instance, in late 2011 FDA detained multiple shipments of children’s medicine being imported by a multi-national drug company. FDA alleged that the drugs appeared to be misbranded and unapproved. Eventually FDA refused all of the shipments. FDAImports.com reviewed … READ MORE
