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.  The eight proposals are … Continue reading

Posted in Advisory Committee Prepapartion, FDA Policy | Comments Off on FDA Making Transparency Increasingly Clear

DDMAC Enforcement Trickles

For some time there has been speculation that enforcement at FDA is up.  But 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