Disclosure of decisive factors in the time of FDA new drug review

Source: from October 28, 2015, the Manhattan Institute released a research report on the efficiency evaluation of FDA new drug approval in April 2014, which was called Center for drug evaluation and Research (CDER) ）There are some differences in the time of new drug review between different drug approval departments, so they think that some departments are more "productive" than others So is the conclusion of this study Tenable? Is the time difference of new drug evaluation determined by work efficiency? Using their own data to analyze, FDA researchers in the United States answered the root cause of the time difference of new drug review between different departments Data and research methods an important responsibility of FDA is to enable patients to get innovative new drugs faster The new drugs that can accelerate the evaluation of early Marketing often have the following characteristics: 1) they are used to treat some serious or life-threatening diseases; 2) they fill the unmet medical needs; 3) they are significantly improved in safety or effectiveness compared with existing drugs FDA shortens the review time of innovative drugs by three means: priority review, fast track review and breakthrough drug review For example, the priority review stipulates that the time for FDA to review the application for new drug listing is 6 months, while the time for standard review is 10 months Using the internal database of FDA, FDA researchers in the United States counted the new drug applications of all small molecule new molecular entity drugs and biological new molecular entity drugs submitted to FDA from October 2002 to September 30, 2012, and calculated the review time of new drugs In 2002-2012, FDA received and approved 250 new drug applications for new molecular entity drugs, of which 117 drugs were priority reviewed, 87 drugs were identified as fast track drugs, and one drug was identified as breakthrough drugs Table 1, figure 1 and Figure 2 show the number of new drug applications received by different departments of FDA CDER and the corresponding median time of review It is found that the time difference of new drug evaluation in different departments is determined by some characteristics of new drugs The reason why the time of new drug review in some departments is short is that these departments receive more new drugs that meet the criteria of accelerated review See the link: http://