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Is Congress Politicizing Patents? Patenting Biotechnology in the Wake of Section 33, Prometheus, and CLS Bank

Posted on July 2012 by Jonathan Stroud

by Jonathan Stroud Is Congress Politicizing Patents? Patenting Biotechnology in the Wake of Section 33 and Prometheus is the timely topic by Author Jonathan Stroud, former Patent Examiner at t...read more

Will Public-Private Research Partnerships Improve Research Funding and Application?

Posted on March 2012 by James M. Solyst

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

Does FDA's Draft Guidance on Responding to Unsolicited Off-Label Requests Align with FDA's Mission to Promote the Public Health?

Posted on March 2012 by Jamie Kendall and Noah Mallon

by Jamie Kendall and Noah Mallon The authors assert that FDA’s vagueness in the December 27, 2011-released Draft Guidance for Responding to Unsolicited Requests for Off-Label Information (&l...read more

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

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

Are Misdemeanor Prosecutions Under the Park Doctrine an Effective Mechanism for Deterring Violations of the Federal Food, Drug, and Cosmetic Act?

Posted on July 2011 by Ariel Galsner

Does FDA Have Enough Funding to Fulfill Its Critical Role in Protecting the Public Health?

Posted on July 2011 by Lad Wiley, Steven A. Grossman

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