Zdrowie i gospodarka · 22/10/2014
Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection." The Food and Drug Administration Safety and Innovation Act (FDASIA) added a provision to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that makes a drug adulterated. This guidance defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.