Analysis of FDA Novel Drug Approvals
Ajay Kumar Shukla1, Rekha Mehani2, Swati Jain2 and Sheema Maqsood21AIIMS, Bhopal
2RKDF MCH RC Bhopal
Corresponding Author Email: drsheemamaqsood@gmail.com
Abstract: Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for the protection of public health by assuring that foods are safe, wholesome, sanitary and, properly labeled. Novel drug Approvals are usually innovative products to serve unmet medical needs or otherwise help to advance patient care. Methods: FDA novel drug approvals were analyzed from calendar year (CY) 2012 to 2018 based on not only their numbers but also BASED ON their impact, innovation, access, and predictability. Results: The total number of novel drugs approved from CY 2012 to 2018 was 279 (average 40 novel drugs/ year). Impact of novel drug approvals: 50% were first in class and 43% were for rare diseases. Overall expedited development and review methods were used in 63% of the novel drug approvals. Access of novel drug approvals: 84% were first-cycle approval, 74% were approved in the US before other countries, 58% priority reviews among novel drug approvals. Predictability of novel drug approvals: 98% approvals able to meet PDUFA goal dates for application review. Conclusions: Novel drug approvals during CY 2012-2018 had a high quality which is very much evident by their high impact, good access, and high predictability.
Keywords: BLA; FDA; NDA; NME; Novel drug approvals Back to TOC