RESUMEN
Combination products face unique R&D, manufacturing, clinical, and regulatory challenges compared to individual devices, drugs, or biological products. Based on the interpretation of the relevant policies and the latest principles of combination products, this paper expounds the FDA's guidance, application trends, and application strategies for the pre-market pathways of combination products, with a view to providing relevant information for Chinese researchers and manufacturers when they start to entry the United States market.
Asunto(s)
Comercio , Seguridad de Productos para el Consumidor , Publicidad Directa al Consumidor , Estados Unidos , United States Food and Drug AdministrationRESUMEN
Drug-device combination product, which comprises at least a drug and a medical device, has been proved to effectively reduce the risk of complications accompanied with conventional medical devices implantation, and has a great clinical success especially in implantable therapeutics. Herein, we firstly elaborated the definitions and requirements of drug-device combination product in different countries, then summarized the market application and research development of typical drug-device combination products. Technical problems and the trend of future development had also been analyzed.
Asunto(s)
Sistemas de Liberación de Medicamentos/instrumentación , Diseño de Equipo , Prótesis e ImplantesRESUMEN
This article summarizes the attribute conditions to the combination products designation from 2009 to 2018 in China,analyzes the common problems of combination products attribution definition.It is hoped to be helpful for researchers and manufacturers of combination products.
Asunto(s)
China , Equipos y Suministros , Terminología como AsuntoRESUMEN
To deal with effectively acute chemical injury events, the service ability of protective medicine against chemical weapons has being widened from dealing with traditional chemical warfare to public chemical accident or chemical terrorist attack. Focusing on the important researching and developing of medicine for chemical defense use only, the novel drug/device combination products should be vigorously promoted including the new mechanism, good curative effect and high safety of detoxification drugs such as hydroxycobalamin used in the treatment of known or suspected cyanide poisoning in both adults and the pediatric population, and the convenient and quick drug delivering technologies such as auto-injectors with a retreat hidden needle and a smart remindful injection, which could improve greatly the emergency medical rescue ability of chemical accidents.
RESUMEN
To deal with effectively acute chemical injury events,the service ability of protective medicine against chemical weapons has being widened from dealing with traditional chemical warfare to public chemical accident or chemical terrorist attack. Fo?cusing on the important researching and developing of medicine for chemical defense use only,the novel drug/device combination products should be vigorously promoted including the new mechanism,good curative effect and high safety of detoxification drugs such as hydroxycobalamin used in the treatment of known or suspected cyanide poisoning in both adults and the pediatric population ,and the convenient and quick drug delivering technologies such as auto-injectors with a retreat hidden needle and a smart remindful injec?tion,which could improve greatly the emergency medical rescue ability of chemical accidents.
RESUMEN
Auto-injector, a spring-driven drug-device based combination production that automatically injects the drug into the skin via a pre-filled syringe or cartridge, allows minimally trained individuals to self-inject potentially life-saving medication when emergency medical care may be absent or remote, and thus has been becoming a supporting approach of emergency medicine for the first-aid. The auto-injector was developed originally by the United State of America, and experienced the three outstanding states including syrettes, single chamber auto-injectors and dual chamber auto-injectors from the battlefield to the civilianization. The current auto-injector devices have five different types named as ACE (AtroPen), ComboPen, Binaject, Soluject and Truject, respectively. The applied drugs to the systems for military use have atropine, pralidoxime chloride, obidoxime, diazepam and morphine sulfate. The other drugs for emergency medical use such as epinephrine, lidocaine hydrochloride and sumatriptan have been also applied to. All of the auto-injector based combination production have been twined with a simulator in order to conduct a training schedule before use. Importantly, the needle hidden or the device-status notification technique after injection has been becoming a trend in the technology advances of the auto-injectors.
RESUMEN
Auto-injector, a spring-driven drug-device based combination production that automatically injects the drug into the skin via a pre-filled syringe or cartridge, allows minimally trained individuals to self-inject potentially life-saving medication when e-mergency medical care may be absent or remote, and thus has been becoming a supporting approach of emergency medicine for the first-aid. The auto-injector was developed originally by the United State of America, and experienced the three outstanding states in-cluding syrettes, single chamber auto-injectors and dual chamber auto-injectors from the battlefield to the civilianization. The current auto-injector devices have five different types named as ACE (AtroPen), ComboPen, Binaject, Soluject and Truject, respectively. The applied drugs to the systems for military use have atropine, pralidoxime chloride, obidoxime, diazepam and morphine sulfate. The oth-er drugs for emergency medical use such as epinephrine, lidocaine hydrochloride and sumatriptan have been also applied to. All of the auto-injector based combination production have been twined with a simulator in order to conduct a training schedule before use. Importantly, the needle hidden or the device-status notification technique after injection has been becoming a trend in the technology advances of the auto-injectors.