FDA Drug Approvals goes down in 2016 like never before

FDA drug

It looks like last year was a bit disappointing for new drug approvals.  The United States Food & Drug Administration (FDA) has approved only 23 new medicines in the entire year. Approvals for many new drugs have been cancelled. This is very least number of approvals since 2010.  In 2014 and 2015 the approvals of new drugs have increased like never before and got new medicines into the market.

The pharmaceuticals industry has seen a spike in previous years and there are only few approvals for new drugs in 2016. In these drug permissions few of them were rejected and some of the drug approvals were delayed and may get approval in 2017.  However it is challenging for the companies who got drug approvals for getting the return on investment.

According to some sources, Deloitte invested lot of funds on R&D for top 10 pharmaceutical companies but got only 3.7 % return which is very low when compared to 10.3% in 2010. It is a big challenge for pharmaceutical companies to develop medicines according to niche populations. There are also several government norms for each country. They differ from country to country.

Moreover, in 2016 the Food & Drug Administration (FDA) received only 37 applications out of which only 23 of the applications were approved. This is a big downfall for the pharmaceuticals industry. This downfall of drug approvals will make pharmaceutical companies to go back to their normal production.


While United States Food& Drug Administration (FDA) approved only 23 new medicines, the European Medicines Agency (EMA) approved 81 new medicines. Both FDA and EMA approved lower number of drugs when compared to past years. FDA approved 45 in 2016 while EMA approved 95 in last year.

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