What is it about?
Drug eluting Stents are combination of drug and device. Drug Substance is anti neoplastic agent and device is a high risk medical technology. There are requirements for device manufacturers to fulfill before gaining marketing authorization in the said regions. Paper identifies the clinical and non-clinical requirements, along with step by step procedure to obtain authorization.
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Why is it important?
DES represent sophistication of modern medical technology and present a challenging case before regulators of all the regions. Manufacturers across the world need a harmonized platform of regulation for unencumbered regulatory support.
Perspectives
This paper identifies the requirements and procedure for Marketing authorization. All the information is presented in a comparative grid, which could serve as a guidance document for firms indulging in regulatory affairs or consulting in drug eluting coronary stents.
Rohin Sethi
DIPSAR
Read the Original
This page is a summary of: A Comparative study of marketing authorization of Drug Eluting Coronary Stents (DES) in India and developed countries (USA & EU), Applied Clinical Research Clinical Trials and Regulatory Affairs, November 2017, Bentham Science Publishers,
DOI: 10.2174/2213476x04666171115155031.
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