FDA recently announced that it intends to “vigorously enforce requirements” relating to postmarket studies and clinical trials for approved drugs.  Among the many provisions of the 2007 FDA Amendments Act (FDAAA), is the expanded authority of the Agency to enforce such postmarketing requirements (PMRs) in an effort to ensure that drugs already approved and marketed remain safe, effective, and of the highest standard of quality.

In the Notice to Industry, FDA indicated that PMRs—which may be required either at the time of approval or anytime thereafter—could include studies and clinical trials (quoted):

  • To assess a known serious risk related to the use of the drug;
  • To assess signals of a serious risk related to the use of the drug; and
  • To identify an unexpected serious risk when available data indicate the potential for serious risk.

It seems that Pearl clients will continue to see this trend of increased requirements for PMRs, increased clinical, and continued regulatory interactions beyond the date of approval.  For more information or to read FDA’s notice, click here.