As discussed in an earlier blog post, US President Donald Trump signed the Further Consolidated Appropriations Act, 2020, into law on December 20, 2019, which includes bipartisan legislation intended to facilitate the development of generic and biosimilar products. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act enhances access by generic manufacturers to brand-name drug samples for the development of generic versions.
Our colleagues at our As Prescribed blog provide additional details about the CREATES Act in a recent post, Congress to Pharma: Hand Over Those Samples.