federal_register: 99-20088

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
99-20088 Changes to an Approved NDA or ANDA; Proposed Rule and Draft Companion Guidance; Public Meeting Proposed Rule The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed amendments to its regulations on postapproval changes to the chemistry, manufacturing, and controls of approved drugs, and a draft companion guidance. FDA is inviting interested parties, including industry, health professionals, patients, and patient advocacy groups to present their perspectives on the proposed amendments and the draft companion guidance. 1999-08-05 1999 8 https://www.federalregister.gov/documents/1999/08/05/99-20088/changes-to-an-approved-nda-or-anda-proposed-rule-and-draft-companion-guidance-public-meeting https://www.govinfo.gov/content/pkg/FR-1999-08-05/pdf/99-20088.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed amendments to its regulations on postapproval changes to the chemistry, manufacturing, and controls of approved drugs, and a draft companion guidance. FDA is...

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