federal_register: 02-16797

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
02-16797 Guidance for Industry on Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products-Chemistry, Manufacturing, and Controls Documentation; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation." This document provides guidance for industry on the chemistry, manufacturing, and controls documentation that should be submitted in new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for nasal spray and inhalation solution, suspension, and spray drug products intended for local and/or systemic effect. The guidance also provides recommendations on labeling. 2002-07-05 2002 7 https://www.federalregister.gov/documents/2002/07/05/02-16797/guidance-for-industry-on-nasal-spray-and-inhalation-solution-suspension-and-spray-drug https://www.govinfo.gov/content/pkg/FR-2002-07-05/pdf/02-16797.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 "Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation." This document...

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