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
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
Overview of FDA-Approved Biologic-Device Combination Products The introduction of medical device to the biopharmaceutical industry has forested numerous biologic-device combination products. From January 2000 to August 2023, there have been 63 biologic-device combination products approved by the U.S. FDA...
now limited to original PMAs, to certain PMA supplements. In the agency’s experience, reviews of applications that are supplements to an already approved device do not ordinarily lend themselves to a modular
reviews of applications that are supplements to an already approved device do not ordinarily lend themselves to a modular format because the changes do not usually involve multiple modules. In addition, the agency currently does not have the resources that would be required to expand the program. ...
Combination products regulation at the FDA. Clin Pharmacol Ther. 2009; 85 :468–470.Lauritsen KJ, Nguyen T. Combination products regulation at the FDA. Clin Pharmacol Ther 2009; 85(5): 468-70.Lauritsen KJ, Nguyen T. Combination products regulation at the FDA. Clin Pharmacol Ther 2009; 85:...
Combination products 2.0: applying the new FDA regulations: combination products, those that contain medical devices embedded with pharmaceutical or biologic components, have become a large and growing segment of the medical device market. Some analysts estimate they represent oven 30% of all new ...
美国FDA 指导原则 根据《联邦食品、药物和化妆品法工业指南》第801(D)(1)(B)条进口FDA批准的某些人类处方药,包括生物制品和组合产品 英文原版.pdf,Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Produ
Purple Book (database of FDA-licensed (approved) biological products, including biosimilar and interchangeable products) 紫皮书(FDA许可(批准)的生物制品数据库) 2020.3.23 FDA将生物制品从橙皮书中移除,并为其单独成立了紫皮书板块,这一板块作为较新的版块,收录了细胞、血液、基因治疗、疫苗等各类生物制品的...
identical excipient types to the RLD formulation were selected for the generic product development. The selection of excipient grade and supplier was based on previous formulation experience and knowledge about excipients that have been used successfully in approved products manufactured by roller compaction...