Some Food & Drug Administration guidance documents are clearly more enjoyable for the agency to draft than others.
The July 12 “Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection”
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.
Some Food & Drug Administration guidance documents are clearly more enjoyable for the agency to draft than others.
The July 12 “Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection”