Regulatory Focus™ > News Articles > Science & Technology: The FDA Postmarketing Study Commitments Database: Is it a Fair Reflection of

Science & Technology: The FDA Postmarketing Study Commitments Database: Is it a Fair Reflection of Industry Compliance?

Posted 01 September 2008 | By

On 30 April 2008, the US Food and Drug Administration (FDA) issued its annual notice, Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies for Fiscal 2007.1 When looking at the numbers, it is striking how little has changed since FDA began to issue these reports in 2002. Approximately two-thirds of all open NDA postmarketing commitment studies (PMCs) are in "pending" status (meaning that no subjects have been enrolled, but the original projected date for initiation of subject accrual or initiation has not yet passed). Far fewer of the studies (less than 25%) are "ongoing" (proceeding according to or ahead of the original schedule) or have been "submitted" (a final study report submitted to FDA). A very small proportion of open studies are "delayed" (behind schedule) or "terminated" (have ended before completion with no final study report submitted). These proportions have been roughly consistent since 2002 (see Table 1 and Figure 1).

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