GPhA: User Fees, ANDA Backlog Should Be Director's Priority

April Hollis

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GPhA: User Fees, ANDA Backlog Should Be Director's Priority

机译：GPhA：使用费，ANDA待办事项应为主管的优先事项

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The Generic Pharmaceutical Association (GPhA) hopes the next permanent director of the FDA's Office of Generic Drugs (OGD) makes clearing the ANDA backlog and establishing generic user fees a top priority.rnFormer OGD Director Gary Buehler stepped down March 4 and will be temporarily replaced by Keith Webber, deputy director of the Office of Pharmaceutical Science (OPS), which oversees the OGD, OPS Director Helen Winkle said recently.

机译：通用药物协会（GPhA）希望FDA通用药物办公室（OGD）的下一任常任理事将清除ANDA积压和建立通用用户费用列为重中之重。前OGD主管Gary Buehler于3月4日卸任，并将被临时取代OPS主任海伦·温克尔（Helen Winkle）最近说，由负责监督OGD的药物科学办公室（OPS）副主任Keith Webber表示。

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《Washington Drug Letter》 |2010年第11期|7|共1页
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April Hollis;
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1. FDA Official Says Generic User Fees Would Alleviate ANDA Backlog [J] . David Belian Washington Drug Letter . 2011,第8期

机译：FDA官员表示，通用用户费用将减轻ANDA的积压
2. FDA Pursues Generic User Fees To Address ANDA Backlog [J] . April Hollis Washington Drug Letter . 2010,第8期

机译：FDA收取通用用户费用以解决ANDA积压问题
3. Speedier Reviews, User Fees Face New CDRH Director [J] . AAMI news . 2004,第8期

机译：更快的评论，用户费用面对新的CDRH总监
4. A REAL WORLD TEST OF ROAD USER FEES: EVALUATING MINNESOTA'S MILEAGE-BASED USER FEE TEST [C] . Christopher Armstrong, Nicholas Kehoe, Sheryl Miller, Transportation Research Board Annual meeting . 2013

机译：道路用户费用的真实测试：评估明尼苏达州基于里程的用户费用测试
5. When is a User Fee Actually a User Fee? Design and Implementation Challenges Faced by Canadian Municipalities. [D] . Farish, Kelly Isabel Emmerson. 2012

机译：使用费实际上是什么时候使用费？加拿大市政当局面临的设计和实施挑战。
6. Experiences opinions and current policies on users’ choice and change of the allocated primary mental health professional: a survey among directors of community mental health centers in the Emilia-Romagna region Italy [O] . G. Rioli, S. Ferrari, C. Henderson, 2020

机译：用户选择和变更分配的主要精神卫生专业人员的经验意见和现行政策：意大利艾米利亚—罗马涅地区社区精神卫生中心负责人的调查
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GPhA: User Fees, ANDA Backlog Should Be Director's Priority

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