New US policies announced to clear the way for generics

Scott Gottlieb, the Commissioner of the US Food and Drug Administration, has announced new policies to make it easier for the manufacturers of complex generics to get their drugs to market.

The steps being taken include issuing draft guidance to assist generic drugmakers to work more closely with the FDA throughout development, and to show how advances in regulatory science can allow generic drug development that was not previously possible.

Further policies aimed at spurring competition to complex drugs are to be released by the FDA in the coming months.