federal_register: 2013-07432

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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
2013-07432 Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment Addendum; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) draft guidance for industry entitled "SUPAC: Manufacturing Equipment Addendum." This revised draft document combines and supersedes "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 has now revised the draft manufacturing equipment addenda to remove the equipment examples and to clarify the types of processes being referenced. 2013-04-01 2013 4 https://www.federalregister.gov/documents/2013/04/01/2013-07432/draft-guidance-for-industry-on-scale-up-and-post-approval-changes-manufacturing-equipment-addendum https://www.govinfo.gov/content/pkg/FR-2013-04-01/pdf/2013-07432.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The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) draft guidance for industry entitled "SUPAC: Manufacturing Equipment Addendum." This revised draft document combines and supersedes...  

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