Antibiotic Development Incentives Face Critical Test As NDA Reviews Begin

20 Jan 2014

• By Cathy Dombrowski

Law has encouraged FDA to be flexible on data requirements for antibiotics, according to sponsors.

The environment for antibiotics development became a friendlier place for sponsors in 2013 with FDA’s implementation of the Generating Antibiotic Incentives Now (GAIN) Act, but just how much the economic incentives of GAIN will change the antibiotics landscape will become clearer in 2014.

The agency’s list of GAIN activities in 2013 included a proposed list of pathogens that have the potential to pose...