Corroboration Development and Regulatory approval of Fibrin Sealant

  • Avni Shah Asst Manager RA
  • Viqar Ahmed R&D - Head
  • Piyush Patel QC - Head
  • Bhavin Trivedi RA - Head
  • Vidya Sagar Head - RA & QA

Abstract

Objective


Finding the relation between scientific evidence development and regulatory approval of medical devices in existing markets, USA (United states of America) and EU (European Union)


Design


To understand this relation, we used evidence development of fibrin sealant as a case study. In general fibrin sealant is a good case study because there is a lot of information available about it.


A systematic review method based on the Cochrane handbook was used to find the evidence development regarding fibrin sealant. We investigated different indications of fibrin sealant, the year of publication, and the phases in clinical trials. To find the procedures and requirements of the approval for fibrin sealant, we searched the government website of their regulatory agencies FDA (Food and Drug Administration), EMA (European Medicine Agency), and CFDA (China Food and Drug Administration).


Results


The relation between evidence development and approval, we found that the cumulative publications of fibrin sealant increased almost in a straight line from 1998 to 2019. Regarding the applications of fibrin sealant, in the first four years after 1998, no new applications were approved, the next four years, two applications were approved, in the four years after that, there were four new applications.


Conclusions


In the first years, the amount of new approved applications is very low, compared to the amount of new publications, but afterwards it goes much faster. Even though fibrin sealant seems to be a Medical Device, the regulatory approval takes time to catch up. For the future research, it would be interesting to also include sales data of fibrin sealant to analyse how sales data influences the medical device companies’ strategies for publication and market approval.

Keywords: Regulatory approval, Fibrin sealant, FDA, EMA, CFDA, Medical Device

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How to Cite
Avni Shah, Viqar Ahmed, Piyush Patel, Bhavin Trivedi, and V. Sagar. “Corroboration Development and Regulatory Approval of Fibrin Sealant”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 1, Mar. 2021, pp. 1-9, doi:10.22270/ijdra.v9i1.445.