FDA Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
Title:
FDA Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
Origin/Publisher:
FDA
Content:
Section 707(b) of FDASIA required the Food and Drug Administration (FDA) to issue guidance that defined the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j).