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The Regulatory Landscape for Drug Compounding: 10 Years After the NECC Outbreak
Manage episode 349194761 series 3413447
Kandungan disediakan oleh Ropes & Gray LLP and Gray LLP. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Ropes & Gray LLP and Gray LLP atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.player.fm/legal.
This episode of Ropes & Gray’s podcast series Non-binding Guidance examines the regulatory landscape for drug compounding and how it has evolved over the last 10 years since a 2012 nationwide fungal meningitis outbreak caused by contaminated drugs from the New England Compounding Center (NECC) rocked the industry and led to a legislative overhaul. Listen to FDA regulatory partner Josh Oyster and associate Becca Williams as they discuss the continuing ramifications of the outbreak, the challenges faced by FDA and drug compounders, the opportunities presented to investors in the life sciences industry, and key areas of regulatory development to watch.
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