Nearly four years after introduction and a half-dozen legislative attempts, proposal to establish academic centers of excellence – hoped to help usher in a renaissance in US pharmaceutical manufacturing – secures passage in omnibus spending bill. New law also supports emerging technologies, building on the FDA’s Critical Path Initiative.

The draft bipartisan user fee reauthorization bill includes more than 40 ride-along provisions to make changes at the US FDA. But there are at least three other bills moving in Congress that also make FDA reforms.

The $1m-$10m penalties prescribed on erring global manufacturers in the US COMPETES Act will create quality differentiators, Strides CEO R Ananthanarayanan believes. He also discusses the potential that Mark Cuban’s firm holds for Indian companies and Strides' evaluation of upcoming HIV therapies.