Current Edition

Regulatory Trends and Developments in the Pharmaceutical Industry in 2018

In the 2017 fiscal year, the FDA issued 114 warning letters to pharmaceutical manufacturers contravening Current Good Manufacturing practices (cGMPs). This followed a trend of continual increase in warning letters, with 102 issued in FY2016 and 42 issued in FY2015. Though this rise suggests that pharmaceutical companies are slacking in the field of
compliance, it is more likely to be a reflection of increased scrutiny within the FDA and of evolving areas of focus. In this article, Jennifer Lopez from Maetrics explores why this is the case, and looks at lessons learnt from this increased scrutiny.