在我们觉得FDA外部专家委员会(advisory committee)制度很不错的时候,FDA对它不满意,希望进行改革。 2024年7月9日,药时代直播间回放了FDA针对如何优化外部专家委员会(advisory committee)而举办的公开会议。 (图片来源:直播截屏) 该会于6月13日举办,从上午9点一直开到下午4点,历时7个多小时,现任FDA局长罗伯特·卡利...
GlaxoSmithKline has announced that the FDA's Vaccines and Related Biological Products Advisory Committee voted that clinical data support both the efficacy and safety of Cervarix, the company's candidate cervical cancer vaccine.Alaina ScottSenior EditorDrug Topics E-News...
On June 4, the Food and Drug Administration (FDA) held a meeting of its Psychopharmacologic Drugs Advisory Committee. The FDA maintains 50 independent committees focused on different fields. Although not required to, it convenes these expert panels when facing difficult decisions.1 In this...
The FDA announced the creation of a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual real...
February 15, 2024 — Abbott announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the U.S. Food and Drug Administration (FDA) confirmed 13 to 1, with 0 abstention that the benefits of Abbott's TriClip™ transcatheter edge-to-e...
The FDA will live stream the advisory committee meeting and a webcast of the meeting will also be available on the FDA website. Subscribe to our e-Newsletters Stay up to date with the latest news, articles, and events. Plus, get special offers ...
The FDA’s newest Digital Health Advisory Committee will explore AI/ML, AR, VR, digital therapeutics, wearables, remote patient monitoring, and more.
FDA现有不同领域的专家咨询委员会三十多个,其中对应CDER相关的药物领域委员会18个,在咱们国内可能听说最多的就是ODAC(Oncologic Drugs Advisory Committee,肿瘤药物专家咨询委员会),去年托Aducanumab和罗沙司他的福,让我们也听闻了PCNSDAC(Peripheral and Central Nervous System Drugs Advisory Committee,外周和中枢神经系统...
Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously that the data from Eisai's Phase 3 Cl...
vice president, global clinical development, Merck Research Laboratories. “We look forward to a productive conversation with the FDA’s Oncologic Drugs Advisory Committee regarding the role of PD-L1 expression as...