OBJECTIVES:  Five years ago the United States government passed the Food and Drug Administration Amendments Act of 2007 (FDAAA) expanding the FDA’s authority to require post-marketing studies.  Prior to this, pregnancy registries, a valuable tool for studying the teratogenicity of newly marketed drugs, were primarily voluntary efforts. Both the FDA (2002) and EMA (2005) issued guidance on post-marketing studies during pregnancy.  The objectives of this research were to evaluate the impact of FDAAA on childbearing populations and trends in post-marketing commitments/requirements (PMC/Rs). METHODS:  Publicly available FDA databases were analyzed to identify all new molecular entities approved between January 2008 and May 2012 and associated PMC/Rs and REMS related to pregnancy/lactation in humans.  Data was augmented from the FDA’s list of pregnancy registries and assigned pregnancy drug category. RESULTS:  Over the 4.5 year period, the FDA approved 125 new compounds (100 drugs, 25 biologics).  Overall 78% had at least one PMC/R (79% of drugs, 84% of biologics).  The proportion of new drugs with a pregnancy related PMC/R was 9% overall and increased over time from 5% in 2008 to a peak of 19% in 2010 before declining to 4% in 2011.  Pregnancy categories were B (26), C (70), D (17), X (12).  Of the 57 pregnancy registries listed on the FDA’s website, 13 are associated with drugs approved during the time period under study however only 6 of these were PMC/R and all were for category C compounds.  A single category X drug had a pregnancy/lactation related PMC/R. CONCLUSIONS:  The majority of pregnancy registries are for medicines with FDA assigned pregnancy category C. Category X drugs are not more likely to have REMS or PMC/Rs despite their known potential for reproductive harm.  Population characteristics such as gender, age, and indication for the prescription are powerful indicators of when PMC/Rs are necessary.