Monday, July 22, 2013
FDA's latest draft guidance for antibiotics ticks a box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