去年,由于 Wegovy 和 Zepbound 均被列入 FDA 药品短缺名单,配制药药房(compounding pharmacies)得以生产这些 GLP-1 药物的非品牌版本,与原研药展开竞争。然而,配制药市场的黄金期即将结束。Zepbound 已于去年 12 月被移出 FDA 药品短缺名单,Wegovy 也于今年 2 月退出,尽管配制药行业协会已分别对这两项移除决定...
proper implementation should not be seen as a regulatory burden when compared to the costs of noncompliance––a point made clear in 2012 when improper compounding at the New England Compounding Pharmacy sparked an outbreak of fungal meningitis which resulted in 64 deaths, hundreds of injuries, and...
Regarding the seven factors, Capps said that drug delivery system, drug formulation and consistency, and drug bioavailability are "irrelevant to the practice of pharmacy compounding," and the other four factors are "so poorly defined that if rigidly applied in their current form, could eliminate vi...
去年,由于 Wegovy 和 Zepbound 均被列入 FDA 药品短缺名单,配制药药房(compounding pharmacies)得以生产这些 GLP-1 药物的非品牌版本,与原研药展开竞争。然而,配制药市场的黄金期即将结束。Zepbound 已于去年 12 月被移出 FDA 药品短缺名单,Wegovy 也于今年 2 月退出,尽管配制药行业协会已分别对这两项移除决定提起...
JonesDay
In addition, PhRMA admonished Hims & Hers for appearing to violate guidelines set by the Alliance for Pharmacy Compounding, which say non-FDA-approved drugs can’t be promoted as safe and effective for treating a particular condition. Health risks aside, the Obesity Society (TOS) wasn’t impr...
FDA 在拟议规章中确定了将特定药物或药物类别列入可证明难以配药(Demonstrable Difficulties for Compounding,DDC)清单的标准: 复杂配方; 复杂给药机制; 生物利用度的复杂性; 配药工艺的复杂性; 物理化学或分析检测复杂性 拟议规章很好地概述了 FDA 和利益相关者在过去二十四年中的监管历史和行动,并具体阐述了药品类别...
美国FDA 指导原则 根据《联邦食品、药品和化妆品法》第503B条指定用于复方的原料药的评价 英文原版.pdf,Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry U.S
A Lilly spokesperson said anyone marketing or selling unapproved versions of tirzepatide, the chemical name for its weight-loss drug Zepbound and diabetes medicine Mounjaro, must now stop and begin transitioning patients to FDA-approved medicines. The Alliance for Pharmacy Compounding, which ...
A Lilly spokesperson said anyone marketing or selling unapproved versions of tirzepatide, the chemical name for its weight-loss drug Zepbound and diabetes medicine Mounjaro, must now stop and begin transitioning patients to FDA-approved medicines. The Alliance for Pharmacy Compounding, which represents...