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The culture of compliance & employee training in the heightened era of cGMP enforcement

USA - August 25 2014 With the U.S. Food and Drug Administration's (FDA) heightened focus on current Good Manufacturing Practices (cGMP) pharmaceutical and medical device...

Texas federal court imposes ongoing royalty rather than permanent injunction against alleged trade secret misappropriator

USA - July 15 2014 A Texas federal trial court, finding the absence of any legal precedence to award an ongoing royalty in a trade secret misappropriation case, looked...

2012 Pharma IP & FDA year in review

USA - March 27 2013 On Wednesday, 20 March 2013, we completed our 2012 Pharma IP and FDA Law - Year in Review webinars. We are pleased to include our slides and link to...

Nigamnarayan Acharya.

Is the Second Circuit off base in its off-label ruling?

USA - December 12 2012 While the recent Second Circuit holding in US v. Caronia may be interpreted by some as a significant decision impacting off-label promotion of prescription drugs, it may well be premature for manufacturers to modify compliance policies prohibiting off-label promotion based solely on Caronia....

John C. Serio.

Suing for patent infringement? One form does not fit all in pleading your case

USA - November 29 2012 The Federal Circuit Court of Appeals issued a decision that represents the "latest word" on how to sufficiently plead patent infringement in a complaint....

Michael H. Baniak.