An incremental GAIN

FDA's latest draft guidance for antibiotics ticks a box under the GAIN Act, but companies say it needs a lot more specifics before it will spur the development of new drugs. On the wish list is more clarity on clinical trial endpoints and guidance on surrogate endpoints.

GAIN, which was incorporated into the FDA Safety and Innovation Act that reauthorized prescription drug user fees, provides added exclusivity for antibiotics and earmarks them for Priority Review...