自2005年以来,奥兹匹克、蒙扎罗、韦戈维和泽普邦等GLP-1药物已获美国食品药品监督管理局(FDA)批准用于治疗2型糖尿病。随着这些药物在减肥领域的日益普及,GLP-1类药物需求激增,导致供应短缺。 2024年10月2日,FDA宣布胰高血糖素样肽-1(GLP-1)药物替尔泊肽注射液的短缺问题已"解决"。
随着替瑞帕肽注射剂短缺问题已得到解决并从FDA药物短缺名单中移除,接下来会发生什么?复方GLP-1药物将面临怎样的未来?
福里律师事务所合伙人内特·比弗(医疗器械业务领域联合主席)与大卫·罗森(FDA业务组负责人)将就GLP-1类药物相关议题展开讨论:
- 什么是GLP-1药物?什么是药物短缺?
- 什么是复方药物?它们如何受到药品短缺的影响?
- 司美格鲁肽和替瑞帕肽的药物短缺现状如何?
- 当一种药物从药物短缺名单中移除时会发生什么?
- 美国食品药品监督管理局(FDA)与外包设施协会(OFA)之间的持续诉讼会产生什么影响?
- 特朗普新政府上台后会产生什么影响(如果有的话)?
如需观看本次网络研讨会的录播,请点击此处。
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