US post-marketing studies delayed

In an annual report it is required to publish in the Federal Register, the US Food and Drug Administration noted that 797 (65%) of the post-market studies that pharmaceutical companies said they would carry out after products were approved had not even begun as of September 30, 2005.

28 studies (2%) were listed as "delayed," a further 231 (19%) are described as "ongoing," which is defined as running at or ahead of schedule. Three studies, or less than 1%, were terminated. Only 172 (14%) have been submitted to the agency, according to the FDA report. The studies were agreed to by 54 different pharmaceutical companies.

As for biologics, just 118 (37%) of post-marketing studies were pending and 94 (29%) were on schedule, while 53 (17%) were deemed delayed. 56 studies have already been submitted.