federal_register: 2014-25033

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2014-25033 Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection." The Food and Drug Administration Safety and Innovation Act (FDASIA) added a provision to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that makes a drug adulterated. This guidance defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated. 2014-10-22 2014 10 https://www.federalregister.gov/documents/2014/10/22/2014-25033/guidance-for-industry-on-circumstances-that-constitute-delaying-denying-limiting-or-refusing-a-drug https://www.govinfo.gov/content/pkg/FR-2014-10-22/pdf/2014-25033.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection." The Food and Drug Administration Safety and Innovation...  

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