federal_register: 2014-28256

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-28256 Guidance for Industry on Scale-Up Post-Approval Changes: Manufacturing Equipment Addendum; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) guidance for industry entitled "SUPAC: Manufacturing Equipment Addendum." This replaces the draft guidance of the same name that combined and superseded "SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum," published on January 1, 1999; and "SUPAC-SS: Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum," published as a draft on December 1, 1998. FDA revised the draft manufacturing equipment addenda to remove the equipment examples and to clarify the types of processes being referenced. 2014-12-02 2014 12 https://www.federalregister.gov/documents/2014/12/02/2014-28256/guidance-for-industry-on-scale-up-post-approval-changes-manufacturing-equipment-addendum https://www.govinfo.gov/content/pkg/FR-2014-12-02/pdf/2014-28256.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) guidance for industry entitled "SUPAC: Manufacturing Equipment Addendum." This replaces the draft guidance of the same name that...

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