Zdrowie i gospodarka · 22/10/2014

FDA Releases Guidance on Delaying, Denying, Limiting, or Refusing Drug Inspections

The Food and Drug Administration (FDA) has released a guidance document outlining the circumstances under which a drug manufacturer may be considered to be delaying, denying, limiting, or refusing a drug inspection, in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA). This guidance aims to clarify the FDA's position on when a drug may be deemed adulterated due to inadequate inspection or refusal of entry.