federal_register: 99-13921

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
99-13921 Draft Guidance for Industry on Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products; Chemistry, Manufacturing, and Controls Documentation; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products; Chemistry, Manufacturing, and Controls Documentation.'' This draft document is intended to provide guidance for industry on the chemistry, manufacturing, and controls (CMC) documentation to be submitted in new drug applications (NDA's) and abbreviated new drug applications (ANDA's) for nasal spray and inhalation solution, suspension, and spray drug products. This draft guidance also covers CMC information recommended for inclusion in the NDA's and ANDA's regarding the components, manufacturing process, and associated controls with each of these areas. 1999-06-02 1999 6 https://www.federalregister.gov/documents/1999/06/02/99-13921/draft-guidance-for-industry-on-nasal-spray-and-inhalation-solution-suspension-and-spray-drug https://www.govinfo.gov/content/pkg/FR-1999-06-02/pdf/99-13921.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products; Chemistry, Manufacturing, and Controls Documentation.'' This...

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