n an article published this week in Nature Drug Discovery, FDA senior officials reported that of the cancer drugs that failed to gain market approval in the last decade, about one-third were rejected by FDA due to defects in the clinical trial design, while the rest were unsuccessful because the drug failed to show FDA-acceptable efficacy in treating the disease. FDA officials discussed in details the conditions that lead to the negative FDA decision. The authors emphasized that most of these rejections could have been avoided by having timely meetings with the FDA throughout the development program. Meetings with FDA can be used to uncover potential deficits in drug development programs and discuss strategies to avoid painful outcome of application rejection. This is not the first time FDA has emphasized the importance of formal meetings. There also have been independent statistical analysis of FDA’s decisions that established a direct correlation between the frequency of meetings with the FDA and the approval decisions. This new article does not state any new surprising findings but only a time-tested fact about FDA’s desire to be heavily involved in the development of new drugs. To get a free copy of this article, write to pbrown@fdamap.com.
Article Source: Article in Nature Drug Discovery
