FDA draft covers adverse event reports to IRBs
April 16th 2007The FDA announced the availability of a draft guidance designed to assist the research community in interpreting requirements for submitting reports of unanticipated problems such as certain adverse events reports to Institutional Review Board (IRB).
FTC probes Bristol-Myers Squibb over generic Plavix
April 9th 2007The FTC launched a civil investigation requesting that Bristol-Myers Squibb turn over key documents and information surrounding a reverse-payment deal it and Sanofi-Aventis made with generic firm Apotex to delay market entry of generic clopidogrel bisulfate (Plavix).