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FDA Expands Inspection Guidance To Apply To Device Manufacturers - Healthcare

On December 15, the U.S. Food and Drug Administration (FDA) issued a draft guidance, titled "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection". ....

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FDA Expands Inspection Guidance to Apply to Device Manufacturers | Sheppard Mullin Richter & Hampton LLP

On December 15, the U.S. Food and Drug Administration (FDA) issued a draft guidance, titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device. ....

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Medical Device Manufacturers Now Subject To FDA Inspection Rules

U.S. Food and Drug Administration FDA issued a draft guidance, titled Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection, which clarifies the types of behaviors the that FDA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. ....

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