In the Aftermath of Parens Patriae: Can Private Copycats Still Sue?

Posted on April 2013 by James M. Beck, Counsel, Reed Smith LLP

This issue of our Policy Forum (Volume 3, Number 8, April 24, 2013) — In the Aftermath of Parens Patriae: Can Private Copycats Still Sue? — explains that pharma...read more

Out on a Limb: How Will the Prohibition of Biomedical Research Using Chimpanzees Harm Public Health?

Posted on March 2013 by Fern P. O’Brian, Partner, and Barbara A. Lum, Associate, Thompson Hine, LLP

In this issue of our Policy Forum (Volume 3, Number 5, March 13, 2013) – Out on a Limb: How Will the Prohibition of Biomedical Research Using Chimpanzees Harm Public Health? – examines ...read more

This issue of Policy Forum (Volume 3, Number 4, February 27, 2013) explains the requirements under the Patient Protection and Affordable Health Care Act’s Physician Payment Sunshine...read more

What Does the Second Circuit’s Recent Decision in United States v. Caronia Not Say?

Posted on February 2013 by Geoffrey R. Kaiser, Founder, Kaiser Law Firm, PLLC; Former Chief of Healthcare Fraud Prosecutions, United States Attorney’s Office for the Eastern District of New York

This issue of Policy Forum (Volume 3, Number 3, February 13, 2013) — "What Does the Second Circuit’s Recent Decision in United States v. Caronia Not Say?" — deconstructs the landm...read more

by Thomas N. Bulleit and Sara Kraner Policy Forum (Volume 2, Number 17, September 12, 2012) rebuts a prior issue on whether medical device companies should be owned by physicians – Why P...read more

by Joseph Truhe Volume 2, Number 10, May 23, 2012 -- In FDLI’s latest Policy Forum,  Joseph Truhe, Senior Vice President and General Counsel to PDP Holdings, LLC, asks &l...read more

James M. Solyst of ENVIRON International Corporation makes the argument that, at a time when federal budgets are precarious, the private sector must be prepared to continue to contribute to the sci...read more

by Jamie Kendall and Noah Mallon The authors assert that FDA’s vagueness in the December 27, 2011-released Draft Guidance for Responding to Unsolicited Requests for Off-Label Information (&l...read more

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Must FDA Engage in Rulemaking to Regulate Laboratory-Developed Tests?

Posted on September 2011 by Gail H. Javitt, Katherine Strong Carner

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