federal_register: 2013-16841

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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
2013-16841 Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection."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 new provision to the Food, Drug, and Cosmetic Act (FD&C Act) concerning inspections that would make a drug adulterated. This guidance defines, by way of example, the circumstances that FDA would consider to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated. 2013-07-15 2013 7 https://www.federalregister.gov/documents/2013/07/15/2013-16841/draft-guidance-for-industry-on-circumstances-that-constitute-delaying-denying-limiting-or-refusing-a https://www.govinfo.gov/content/pkg/FR-2013-07-15/pdf/2013-16841.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection." The Food and Drug Administration Safety and...  

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