The proliferation of direct-to-consumer (DTC) genetic testing poses new regulatory challenges as genetic testing and information, once within the exclusive domain of medical institutions, has migrated into the private commercial sector. The FDA’s traditional “protective” medical device...

Biologics accounted for roughly $145 billion in spending in 2018 (IQVIA, 2019). They are also the fastest growing segment of the pharmaceutical industry. The Biological Price Competition and Innovation Act (BPCIA) of 2010 created an abbreviated pathway for biosimilar products to promote price...