 Because of these complexities, the 1984 Hatch-Waxman Act did not include biologics in the Abbreviated New Drug Application (ANDA) process, in essence precluding the possibility of generic drug competition for biotechnology drugs.In February 2007, identical bills were introduced into the House to create an ANDA process for the approval of generic biologics, but were not passed.In 2013, a guidance was issued to regulate mobile medical applications and protect users from their unintended use.