Pharmaceutical Regulatory Affairs: Open Access

Ratna V

Publications

• Review Article
  Post Marketing Surveillance Requirements of Drug Eluting Stents in India and European Union
  Author(s): Swathilakshmi U, Shailaja P, Ratna V, Prasanth S and Daniel BASwathilakshmi U, Shailaja P, Ratna V, Prasanth S and Daniel BA
  
  The objective of present review is to offer an overview of post marketing surveillance of drug eluting stents in India and European Union (EU). The drug eluting stents are used for the treatment of coronary angioplasty Drug eluting stents can significantly reduce the rate of restenosis by 60-75% as compare to bare metal stents. New technologies are often introduced into the market without proper safety and effectiveness data. To know about the safety and effectiveness of the drug eluting stents after marketing, Post marketing surveillance plays a vital role it includes Periodic Safety Update Report (PSUR) and Post Marketing Clinical Follow Up Studies (PMCF) for the identification of residual risk during the process and also explained about the functions of manufacturer and notified bodies, regulatory requi.. Read More»
  DOI: 10.4172/2167-7689.1000192

  Abstract PDF