How To Respond When FDA Knocks

Law360, New York (September 26, 2013, 4:49 PM EDT) -- Recently, the U.S. Food and Drug Administration issued a draft guidance entitled, “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.”[1] Congress required the FDA to issue this guidance within a year of the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA), which strengthened the FDA’s authority regarding inspection refusals so that now delaying, denying, limiting or refusing to permit inspection causes a drug to be adulterated. 21 U.S.C. § 351(j) (a drug is adulterated if “it has been manufactured,...
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