As described in Appendix A, FDA’s listings of labeling changes related to BCPA and PREA (and their predecessor policies) are not complete. Specifically, they do not include changes for biologics that were made prior to September 27, 2007. FDA could not supply the committee with the missing information. Thus, the list provided to the committee understates to an unknown extent the number of labeling changes made as a result of studies of biologics that were required under PREA or the Pediatric Rule.

Figure 7-1 shows the time trend of labeling changes attributed by FDA to BPCA and PREA through October 25, 2011. From 1998 through 2004, the general pattern is one of yearly increases in the number of changes


FIGURE 7-1 Changes in drug labeling associated with BPCA, PREA (including the Pediatric Rule), or both, July 1998 through October 2011. The figure excludes changes for biologics regulated under the Public Health Service Act that were approved before September 27, 2007. It includes changes for some products (e.g., contraceptives) that were excluded from the committee’s analysis as well as one change that is attributed to the 1994 Pediatric Rule.

SOURCE: Compiled from information periodically updated in an Excel file downloadable at

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