{"id":184,"date":"2025-07-12T11:54:11","date_gmt":"2025-07-12T04:54:11","guid":{"rendered":"https:\/\/pythonsonline.com\/index.php\/2025\/07\/12\/fda-menerbitkan-lebih-dari-200-surat-tanggapan-lengkap\/"},"modified":"2025-07-12T11:54:11","modified_gmt":"2025-07-12T04:54:11","slug":"fda-menerbitkan-lebih-dari-200-surat-tanggapan-lengkap","status":"publish","type":"post","link":"https:\/\/pythonsonline.com\/index.php\/2025\/07\/12\/fda-menerbitkan-lebih-dari-200-surat-tanggapan-lengkap\/","title":{"rendered":"FDA menerbitkan lebih dari 200 surat tanggapan lengkap"},"content":{"rendered":"<div>\n<div class=\"\">\n<div style=\"width:30%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:pointer\" class=\" figure\">\n<div id=\"image-caption\" class=\"text-gray-500 italic\">\n<div class=\"blockText_blockContent__TbCXh\">\n<p class=\"pb-2\">Silver Spring, MD, USA &#8211; 25 Juni 2022: Kampus Oak White FDA, markas besar Administrasi Makanan dan Obat -obatan Amerika Serikat, sebuah agen federal dari Departemen Kesehatan dan Layanan Kemanusiaan (HHS) | Kredit Gambar: \u00a9 TADA Images &#8211; stock.adobe.com<\/p>\n<\/div>\n<\/div>\n<div class=\"hidden top-(-100%) block w-(1px) transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden\"><img decoding=\"async\" class=\"m-auto absolute inset-0 max-w-(0%) max-h-(0%) border-(3px) border-solid border-white shadow-(0px_0px_8px_rgba(0,0,0,0.3)) box-border transition ease-in-out duration-500\" src=\"https:\/\/cdn.sanity.io\/images\/0vv8moc6\/pharmtech\/479562cf75024b96c9055ce170fc5ee092146c83-6960x4640.jpg?fit=crop&amp;auto=format\"\/><\/div>\n<\/div>\n<\/div>\n<p class=\"pb-2\">Pada 10 Juli 2025, FDA membuat publik lebih dari 200 surat keputusan rahasia yang sebelumnya &#8211; dikenal sebagai Lengkapi Surat Respons Lengkap (CRLS) &#8211; dikeluarkan antara tahun 2020 dan 2024 untuk aplikasi obat dan biologis yang tidak disetujui selama siklus peninjauan awal mereka (1). Surat -surat ini memberikan alasan terperinci mengapa suatu aplikasi tidak dapat disetujui dalam bentuk yang diajukan, termasuk masalah yang terkait dengan keamanan, kemanjuran, kekurangan manufaktur, dan bioequivalensi (1).<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\"><strong>Langkah yang belum pernah terjadi sebelumnya<\/strong><\/h2>\n<p class=\"pb-2\">Sebelumnya, FDA tidak secara rutin berbagi CRL di depan umum. Sponsor sering mengungkapkan informasi minimal saat mengumumkan tidak persetujuan. Sebuah studi cross-sectional 2015 yang diterbitkan di <em>BMJ<\/em> menemukan bahwa pengembang obat menghilangkan sekitar 85% dari kekhawatiran keselamatan dan kemanjuran yang dicatat oleh FDA dalam pernyataan publik mereka (2). Selain itu, ketika FDA merekomendasikan uji klinis baru, fakta itu ditinggalkan dari komunikasi sponsor pada sekitar 40% kasus.<\/p>\n<p class=\"pb-2\">Surat -surat yang baru dirilis tersedia melalui platform OpenFDA dan dihapus untuk menghapus rahasia dagang atau informasi komersial rahasia (1). Menurut agensi tersebut, hanya CRL yang terkait dengan produk yang disetujui kemudian dimasukkan dalam batch awal ini. FDA sedang meninjau arsipnya dan telah mengindikasikan dapat merilis surat tambahan di masa depan sebagai bagian dari inisiatif transparansi yang lebih luas (1,3).<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\"><strong>Tanggapan campuran<\/strong><\/h2>\n<p class=\"pb-2\">Komisaris FDA Marty Makary, MD, MPH, menyatakan bahwa langkah tersebut dimaksudkan untuk mengurangi &#8220;permainan menebak&#8221; untuk pengembang obat dan investor dan membantu menumbuhkan jalur yang lebih dapat diprediksi untuk persetujuan terapeutik (1).<\/p>\n<p class=\"pb-2\">Kritik terhadap sistem sebelumnya telah lama menunjukkan kurangnya transparansi sebagai faktor dalam kesalahan langkah peraturan berulang di seluruh industri. Ketidakmampuan untuk belajar dari kegagalan orang lain dapat dibilang berkontribusi pada inefisiensi dalam pengembangan klinis dan perencanaan strategis. Publikasi CRLS diharapkan memberi perusahaan dan investor wawasan yang lebih dalam tentang proses pengambilan keputusan agensi dan menyoroti perangkap umum di seluruh domain klinis, manufaktur, dan peraturan (4).<\/p>\n<p class=\"pb-2\">Namun, beberapa pengamat mencatat bahwa rilis menimbulkan pertanyaan tentang konsistensi, waktu, dan ruang lingkup. Misalnya, masih belum jelas apakah CRL di masa depan untuk aplikasi yang tidak disetujui akan dipublikasikan atau apakah sponsor akan memiliki input ke dalam proses redaksi. Analis hukum juga telah menandai pentingnya menjaga perlindungan kerahasiaan sambil memperluas akses ke sejarah peraturan (5).<\/p>\n<p class=\"pb-2\">Sementara reaksi terhadap pergeseran kebijakan telah beragam, publikasi CRLS mewakili perubahan penting dalam bagaimana FDA mengomunikasikan keputusan ulasannya dan dapat menandakan evolusi yang lebih luas dalam standar transparansi peraturan AS.<\/p>\n<p class=\"pb-2\"><strong><br \/>Referensi<\/strong><\/p>\n<ol class=\"my-2\">\n<li class=\"list-decimal ml-8\">FDA. FDA mencakup transparansi radikal dengan menerbitkan huruf respons lengkap. Siaran pers. 10 Juli 2025.<\/li>\n<li class=\"list-decimal ml-8\">Downing N, Ross J, dkk. Menjelaskan konten surat tanggapan lengkap FDA dan bagaimana sponsor melaporkannya secara publik: studi cross sectional<em>.<\/em> <em>BMJ<\/em> 2015; 350: H2758.<\/li>\n<li class=\"list-decimal ml-8\">Mason, G.FDA melepaskan &#39;batch awal&#39; dari lebih dari 200 surat penolakan narkoba<em>.<\/em> <em>Biotech sengit<\/em>.<\/li>\n<li class=\"list-decimal ml-8\">Halpern L. FDA menerbitkan ratusan surat tanggapan lengkap dari paruh pertama dekade ini<em>.<\/em> <em>Waktu farmasi<\/em>.<\/li>\n<li class=\"list-decimal ml-8\">Hogan Lovells. Penciptaan database publik FDA yang terdiri dari 200 CRL menimbulkan pertanyaan. Siaran pers. 10 Juli 2025.<\/li>\n<\/ol>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Silver Spring, MD, USA &#8211; 25 Juni 2022: Kampus Oak White FDA, markas besar Administrasi Makanan dan Obat -obatan Amerika Serikat, sebuah agen federal dari Departemen Kesehatan dan Layanan Kemanusiaan (HHS) | Kredit Gambar: \u00a9 TADA Images &#8211; stock.adobe.com Pada 10 Juli 2025, FDA membuat publik lebih dari 200 surat keputusan rahasia yang sebelumnya &#8211; [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":185,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-184","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA menerbitkan lebih dari 200 surat tanggapan lengkap - 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