Jingwen Weng, Qiurong Zhu, Fangyuan Zhou, Quanmin Chen, Xuejun Gu, Weichang Zhou. A review of recent FDA-approved biologic-device combination products. J Pharm Sci. 2023. doi: https://doi
Drug-device combination products associate a drug with a medical device, and hence bridge different regulatory frameworks(drug or device). Drug-device combinations can be single products comprised of several components – e.g. transdermal patches, drug-eluting stents – separate products packaged togeth...
These can vary widely depending on how the FDA views the combination product (as a drug, device, or biologic). Last, the issues which the FDA and applicants are dealing with as the process of regulation of new technology continues to develop and change, with some insight into FDA action ...
This is particularly the case with single, integral products designed for the drug and device to be used exclusively in a specific, non-reusable combination, such as a prefilled syringe or prefilled autoinjector. This approach would necessitate the drug and device, especially their interaction, ...
一般来说,FDA不建议对以下情况提交CP: ●不明确的CMC变更计划(例如,"修改生产过程")。 ●对产品的改变难以定性,对产品质量的影响无法通过前瞻性的测试、研究、分析程序和验收标准来确定 ●需要从非临床安全性、药代动力学/药效学或临床安全性或疗效研究中获得支持性数据以评估变化的影响的变化(例如,评估新杂质的毒...
With integral complex and innovative combination products, the suitability of the device component would be assessed by the Swiss equivalent of an NB or “some other type of expert opinion,” according to the agency (6). EBE stresses the need for NBs to be clear about their responsibilities in...
A Bayesian active learning platform for scalable combination drug screens Large-scale combination drug screens in cancer are extremely challenging because of the immense number of possible combinations. Here, the authors develop BATCHIE, a Bayesian active learning platform to design scalable and maximall...
A real-world pharmacovigilance study of FDA adverse event reporting system events for Capmatinib Yiming Qi ,Jing Li &Cheng Jiang Article 17 May 2024|Open Access Data mining and safety analysis of avatrombopag: a retrospective pharmacovigilance study based on the US food and drug administration’s...
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A novel compound that has never been approved by a pharmaceutical regulatory agency (e.g., the FDA). Product Enhancement An approved or investigational drug that is being tested to potentially treat another related condition. For example, drugs approved for the treatment of one type of cancer ma...