A retrospective study of Warning Letters issued by US FDA over 2015-2017
Journal Title: International Journal of Drug Regulatory Affairs - Year 2018, Vol 6, Issue 2
Abstract
This paper provides contemporary climate of warning letters issued by US FDA over 2015 to 2017. With 1300$ Billion Revenue in 2017 United States stands as World’s largest Pharmaceutical Market. Being the largest, diversified and due to globalization, US Pharma industry is the most competitive and critical sectors of the economy. So, exporting to the US is a great opportunity which is leveraged by many countries and US FDA was formed to check the quality standards of Medicines. Since the inception of US FDA, it has been giving many warning letters to Pharmaceutical Companies for violating regulatory guidelines. The back bone of this paper is to analyse warning letters and to identify what are the major violations in case of Pharmaceuticals.
Authors and Affiliations
Lakshmi Ananth, Nirmal K. Gurbani, Saurabh Kumar, Bharat Gujavarti
Keywords
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- EP ID EP329321
- DOI 10.22270/ijdra.v6i2.242
- Views 130
- Downloads 0
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