Entries by admin_fidj

Kirtsaeng v. John Wiley & Sons:

U.S. Supreme Court Addresses the First Sale Doctrines Applicability to Goods Produced and Manufactured Abroad On October 29, 2012, the Supreme Court heard oral arguments in Kritsaeng v. John Wiley […]

FDA Issues Draft Guidance and 510(k) Submission Checklist

On August 13, 2012, the U.S. Food and Drug Administration (“FDA“) issued a Draft Guidance document entitled “Refuse to Accept Policy for 510(k)s” (“the Guidance”). The Guidance outlines the procedures […]