Drug industry comments on a draft guidance about Multiple Endpoints in Clinical Trials seek changes and further clarifications about multiplicity.
Federal Register final rule technical amendment: FDA makes revisions to Chapter I of its regulations to eliminate the position of regional food and dr...
FDA clears a Toshiba Medical 510(k) for the Aplio i900 ultrasound platform.
FDA issues AstraZeneca a second complete response letter on its NDA for ZS-9 (sodium zirconium cyclosilicate), indicated for treating hyperkalemia (hi...
FDA clears a DJO Global 510(k) for its Exprt Revision Hip, which claims an 80-90% reduction in instruments from competitors.
Attorney Alan Minsk suggests ways companies should respond to FDA inspections at foreign drug manufacturing facilities.
Federal Register notice: FDA corrects a 12/15/2016 notice entitled Public Meeting on Patient-Focused Drug Development for Sarcopenia to reflect a chan...
FDA constituencies push back on the Trump Administrations fiscal year 2018 budget blueprint that calls on regulated industry to pay twice as much in u...