The U.S. Food and Drug Administration (FDA) has published the revised draft guidance “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device.
On December 15, the U.S. Food and Drug Administration (FDA) issued a draft guidance, titled "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection".
On December 15, the U.S. Food and Drug Administration (FDA) issued a draft guidance, titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device.
U.S. Food and Drug Administration FDA issued a draft guidance, titled Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection, which clarifies the types of behaviors the that FDA may find inappropriate under the FDCA.