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FDA's New Transparency Task Force: Mission And Opportunity For Public Comment
On June 3, the U.S. Food and Drug Administration (FDA or Agency) announced the formation of the FDA Transparency Task Force (Task Force) to solicit public comments and to promulgate recommendations for enhancing the transparency of the FDA's internal activities and decision-making.1As part of its...
Read MoreFDA Publishes Draft Guidance For Industry On Presenting Risk Information During Prescription Drug And Medical Device Promotion
FDA Requests Public Comments By August 25, 2009 In response to industry requests for better insight into how FDA evaluates promotional materials for prescription drugs and medical devices for compliance with statutory and regulatory requirements, FDA issued a Draft Guidance document on May 26...
Read MoreProposed FCA Amendments: A Blow To Healthcare
Editor: Congress presently is considering several proposed amendments to the False Claims Act (FCA) that would overturn court decisions that have limited the application of the FCA and the prosecution of qui tam complaints. What is the status of some of the proposed amendments? Eiland: On May 6,...
Read MoreLead Director Network - Corporate Governance After The Financial Fallout
Editor: What was the thought process behind creating the Lead Director Network? Baxley: The lead director role has been an area with relatively little formal guidance as to how the role should be structured or how directors should conduct themselves. The role itself is relatively new; General...
Read MoreDelaware Supreme Court Reverses Court Of Chancery's Lyondell Decision
In a much anticipated reversal of the Delaware Court of Chancery's controversial opinion in Ryan v. Lyondell Chemical Co. ,1the Delaware Supreme Court recently reaffirmed that Delaware law will not countenance an aggrieved stockholder's attempt to "bootstrap" onto a duty of loyalty claim for...
Read More18th Annual King & Spalding Health Law And Policy Forum: "Hot Topics" In Healthcare Fraud Enforcement - Administrative
Editors Note: The 18th Annual King & Spalding Health Law and Policy Forum took place on February 17, 2009, at the Four Seasons Hotel in Atlanta, Ga. The Forum included a panel discussion of "'Hot Topics' In Healthcare Fraud Enforcement." Our interviewees facilitated the discussion of the...
Read More18th Annual King & Spalding Health Law And Policy Forum: Healthcare Companies Face Unprecedented Challenges
Editors Note: The 18th Annual King & Spalding Health Law and Policy Forum took place on February 17, 2009, at the Four Seasons Hotel in Atlanta, Ga. The Forum led off with a panel discussion of the unprecedented challenges faced by healthcare companies in today's distressed economy. Our...
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