federal_register: 00-28519

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
00-28519 Applications for FDA Approval to Market a New Drug; Proposed Revision of Postmarketing Reporting Requirements Proposed Rule The Food and Drug Administration (FDA) is proposing to amend its regulations describing postmarketing reporting requirements to implement certain provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The proposed changes apply to drug products that are life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition and that were not originally derived from human tissue and replaced by a recombinant product. The proposed rule would implement provisions of the Modernization Act by requiring an applicant who is the sole manufacturer of one of these products to notify FDA at least 6 months before discontinuing manufacture of the drug product. 2000-11-07 2000 11 https://www.federalregister.gov/documents/2000/11/07/00-28519/applications-for-fda-approval-to-market-a-new-drug-proposed-revision-of-postmarketing-reporting https://www.govinfo.gov/content/pkg/FR-2000-11-07/pdf/00-28519.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to amend its regulations describing postmarketing reporting requirements to implement certain provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The...

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