What Not To Do When FDA Comes Knocking
This article was originally published in PharmAsia News
The U.S. FDA tweaks final guidance on what constitutes interference with FDA inspections to include examples of ‘reasonable’ explanations for sponsor delays; industry had requested many other changes.
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FDA has a powerful new tool to assure access to drug manufacturing plants: legislated authority to deem a product adulterated when a company tries to evade inspections: A new guidance elaborates on the situations that FDA will define as obstructionist, and cuts into new territory by defining refusal to provide records in lieu of an inspection as an actionable offence.
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