Monthly Archives: October 2011

FDA Making Transparency Increasingly Clear

This week a number of people took note when the FDA announced the issuance of a report that outlined eight new proposals to increase transparency by allowing greater access to the agency’s compliance and enforcement data. ┬áThe eight proposals are … Continue reading

Posted in Advisory Committee Prepapartion, FDA Policy | Comments Off

DDMAC Enforcement Trickles

For some time there has been speculation that enforcement at FDA is up. ┬áBut it should be noted that regulatory action letters come from several different parts of the agency and encompass much more than promotional communications. For our purposes, … Continue reading

Posted in Uncategorized, Warning Letters | 2 Comments