[4] RegulatoryScience in FDA’s Center for Devices and Radiological Health: A VITAL FRAME WORK FOR PROTECTING AND PROMOTING PUBLIC HEALTH (www.fda.gov/.../aboutfda/centersoffices/officeofmedicalproductsand to bacco/cdrh/cdrhreports/ucm274162.pdf)...
Therapeutic Innovation & Regulatory Scienceis a peer-reviewed journal that focuses on medical product discovery, development, regulation, access, and policy. Official scientific journal of the Drug Information Association (DIA). Provides a platform for researchers, regulators, developers, patient advocacy ...
I belong to the National Institute of Health Sciences (NIHS), Japan. The institute was established in 1874 as the Tokyo Drug Control Laboratory and later renamed the Tokyo Institute of Hygienic Science in 1887. Nowadays, the NIHS regulates the products created by science and technology to ensure...
The World’s Leading Regulatory Science Consultancy ProPharma's aim is to help your business succeed by working to streamline the pharma/biotech/medical device regulatory process. Our experienced team of regulatory consulting and compliance experts commands an unparalleled breadth and depth of knowledge ...
(EMA) has issued guidelines and explanations on compliance issues related to drug–device CPs under MDR. EMA doesn’t have the definitions of CPs, but uses the term drug–device combination products (drug-device CPs). CPs are categorized as drugs or medical devices, which follow their relevant...
regulatory science for medical products by including additional articles and commentary from regula- tory professionals in industry, academia, and government, and by devoting space to the development and regulatory govern- ance of medical devices and companion diagnostics as well as biopharmaceutical drugs...
Harmonization By Doing (HBD), whose activities include the exploratory study on the implementation of global clinical trials, consisting of the members fro... S Iwamoto,HO Mami,Y Suzuki - 《Regulatory Science of Medical Products》 被引量: 1发表: 2015年 Nanotechnology Innovations in Pediatric Card...
In recent years, the development of radiopharmaceuticals for therapy has become active globally, with the entry of major pharmaceutical companies. One of t... A Hachisuka,T Higashi,M Hosono,... - 《Regulatory Science of Medical Products》 被引量: 0发表: 2022年 Strategic Regulatory Evaluation an...
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
In its ‘Regulatory Science Strategy to 2025’ (RSS), the EMA envisages the creation of an integrated evaluation pathway for the assessment of medical devices, in vitro diagnostics and borderline products9. Among the goals of the integrated pathway assessment, three of them are relevant also for...