On Wednesday, the FDA issued a new draft guidance proposing to reduce the need for sponsors to conduct a comparative efficacy study (CES)...

Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought...

FDA recently doubled down on its approach of allowing new language in an ANDA label as the result of a section viii statement – a...

For forty years, Chevron has put a thumb on the scales in favor of the executive agencies whenever their decisions were challenged in...

Over the past year, FTC has placed twosets of Orange Book listings in its crosshairs, but, to date, FTC has not actually begun any...