{"product_id":"fda-epysqli-bla-761340-regulatory-review-rems-records","title":"FDA EPYSQLI BLA 761340 Regulatory Review \u0026 REMS Collection — Samsung Bioepis","description":"\u003cp class=\"PDq2pG_selectionAnchorContainer\"\u003eThis FOIAdocs regulatory document collection brings together FDA review records and regulatory correspondence for EPYSQLI (eculizumab-aagh), BLA 761340, submitted by Samsung Bioepis. The collection contains four substantive FDA records totaling 25 pages and follows the application from the October 2023 mid-cycle review through detailed REMS discussions in March 2024. \u003cspan class=\"contents\"\u003e\u003c\/span\u003e \u003cspan class=\"contents\"\u003e\u003c\/span\u003e \u003cspan class=\"contents\"\u003e\u003c\/span\u003e\u003cspan class=\"PDq2pG_selectionAnchor\"\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003eThe records provide a chronological view of FDA's review, including scientific and CMC information requests, comparative analytical assessment, REMS and ETASU requirements, labeling negotiations, postmarketing requirements and commitments, facility inspections, and detailed FDA feedback on REMS implementation.\u003c\/p\u003e\n\u003ch3\u003eWhat's included\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eOctober 16, 2023 Mid-Cycle Communication\u003c\/li\u003e\n\u003cli\u003eDecember 2023 REMS Information Request and FDA\/applicant correspondence\u003c\/li\u003e\n\u003cli\u003eJanuary 9, 2024 Late-Cycle Meeting Minutes\u003c\/li\u003e\n\u003cli\u003eMarch 28, 2024 detailed FDA REMS comments\u003c\/li\u003e\n\u003cli\u003eFDA information requests addressing statistics and comparative analytical\/CMC issues\u003c\/li\u003e\n\u003cli\u003eREMS requirements, including ETASU A, B, and D\u003c\/li\u003e\n\u003cli\u003eFDA discussions of labeling, postmarketing requirements and commitments, and facility inspections\u003c\/li\u003e\n\u003cli\u003eDetailed REMS feedback covering enrollment, distribution and dispense authorization, REMS operations, website materials, key performance indicators, and assessment requirements\u003c\/li\u003e\n\u003cli\u003eFOIA release documentation for the individual records\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThe October 2023 mid-cycle record includes detailed FDA questions concerning the comparative analytical assessment of SB12 and reference eculizumab products, including analytical methods, reference lots, quality attributes, and scientific justification. Portions of this record were withheld by FDA under FOIA exemption (b)(4). \u003cspan class=\"contents\"\u003e\u003c\/span\u003e \u003cspan class=\"contents\"\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003eThe subsequent records show the progression of FDA's REMS review. In December, FDA instructed Samsung to incorporate additional elements to assure safe use and requested information about product distribution and authorization-to-dispense processes. \u003cspan class=\"contents\"\u003e\u003c\/span\u003e By the January late-cycle meeting, FDA stated that a REMS was necessary and documented ongoing labeling negotiations, anticipated postmarketing requirements and commitments, and facility inspection status. \u003cspan class=\"contents\"\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePackage format:\u003c\/strong\u003e Organized ZIP collection containing the four substantive FDA regulatory records as individual PDFs, plus FOIA release documentation.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eApplication:\u003c\/strong\u003e BLA 761340\u003cbr\u003e\u003cstrong\u003eProduct:\u003c\/strong\u003e EPYSQLI (eculizumab-aagh) \/ SB12\u003cbr\u003e\u003cstrong\u003eApplicant:\u003c\/strong\u003e Samsung Bioepis Co., Ltd.\u003cbr\u003e\u003cstrong\u003eDocuments:\u003c\/strong\u003e 4 substantive FDA regulatory records\u003cbr\u003e\u003cstrong\u003ePages:\u003c\/strong\u003e 25 substantive pages\u003cbr\u003e\u003cstrong\u003eCoverage:\u003c\/strong\u003e October 2023 – March 2024\u003cbr\u003e\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51465661251748,"sku":"FDABLA761340","price":399.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/FDABLA761340.png?v=1788554084","url":"https:\/\/foiadocs.com\/products\/fda-epysqli-bla-761340-regulatory-review-rems-records","provider":"FOIA Document Source","version":"1.0","type":"link"}