Recent Posts

Stryker Biotech Pleads Guilty, Will Pay $15 Million For Promoting Bone Repair Products
Posted on 18 Jan 2012 by Tom Moylan

BOSTON - (Mealey's) Stryker Biotech LLC on Jan. 17 pleaded guilty to one federal misdemeanor count of misbranding a medical device and agreed to a $15 million fine for promoting the mixing of its OP-1 and Calstrux orthopedic repair products to health... Read More

William A. Ruskin: New Draft FDA Guidance On Off-label Uses Raises Concerns
Posted on 28 Mar 2014 by William A. Ruskin

By William A. Ruskin | On March 3, 2014, FDA made available for comment a revised draft of its " Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices ". The revised guidance... Read More

D.C. Circuit Says Former Purdue Pharma Execs Excludable But Questions Term
Posted on 27 Jul 2012 by Tom Moylan

WASHINGTON, D.C. - (Mealey's) The Department of Health and Human Services is authorized to exclude three former Purdue Pharma executives from participating in federal health care programs, but it must explain why it thinks they should be excluded... Read More

William A. Ruskin: First Amendment Bars Pharmaceutical Company Prosecution
Posted on 14 Dec 2012 by William A. Ruskin

By William A. Ruskin The Second Circuit [on Dec. 3] rendered its much-anticipated decision in United States v. Caronia [ enhanced version available to subscribers ], the most important Food Drug and Cosmetics Act enforcement case pending... Read More