Most Recent Articles by James G. DIckinson
Public Citizen tells FDA it should withdraw draft guidance that it believes will allow drugmakers to tell physicians marketed drugs are less risky than their labels indicate.
The former FDA director of medical device compliance has petitioned the agency to make oral contraceptives over-the-counter.
Hospira is taking to the courts to fight off generic threats to its hospital sedation drug Precedex
Two FDA guidance documents on how health product manufacturers may participate in social media have each drawn criticism from affected industry and consumer groups.
The US District Court for Maryland granted Hospira a temporary restraining order (TRO) against FDA, after the agency determined that potential generic competitors of the company's injectable sedation drug Precedex could be approved.