Zdrowie i gospodarka · 16/12/2022

FDA Announces Draft Guidance on Delaying, Denying, Limiting, or Refusing Drug and Device Inspections

The Food and Drug Administration (FDA) has released a draft guidance outlining the circumstances under which a drug or device manufacturer may be deemed adulterated if they delay, deny, or limit an FDA inspection, as mandated by the FDA Reauthorization Act of 2017