Litigation

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Split 6th Circuit: Michigan Drug Shield Law Does Not Apply To Fentanyl Patch
Posted on 21 Jan 2014 by Tom Moylan

CINCINNATI — (Mealey’s) A split Sixth Circuit U.S. Court of Appeals on Jan. 21 reversed dismissal of a fentanyl patch overdose lawsuit, saying the trial court needs to determine whether the patch is a combination product that is not preempted... Read More

Norton Rose Fulbright: FDA’s Expanded Oversight Of ‘High-risk’ Diagnostic Devices
Posted on 7 Aug 2014 by Norton Rose Fulbright

By Cori Annapolen Goldberg and Lidia Niecko-Najjum In efforts to ensure that in vitro diagnostic devices 1 provide accurate, consistent and reliable results, the US Food and Drug Administration ("FDA" or "the Agency") 1) issued... Read More

D.C. Circuit Says FDA Can Regulate Stem Cell Drugs; Company Properly Enjoined
Posted on 4 Feb 2014 by Tom Moylan

WASHINGTON, D.C. — The District of Columbia Circuit U.S. Court of Appeals on Feb. 4 said the federal government can regulate a company that cultures stem cells for injection in the donor patient and said a lower court did not err in permanently... Read More

Ballard Spahr LLP: Pharmaceutical Companies Get Off-Label Marketing Victory
Posted on 18 Aug 2015 by Ballard Spahr LLP

. . . A federal judge ruled that the Food and Drug Administration (FDA) cannot prohibit a pharmaceutical company from marketing its drugs for off-label uses if its claims are truthful and not misleading. This ruling, while not precedential, alters the... Read More

2nd Circuit Lifts Stay On 2-Pill Plan B Contraceptive, Expedites FDA's Appeal
Posted on 8 Jun 2013 by Tom Moylan

NEW YORK - (Mealey's) The Second Circuit U.S. Court of Appeals on June 5 said the federal government failed to meet the standard to obtain a stay of a lower court order that the Food and Drug Administration immediately make the older, two-pill Plan... Read More

Former Acting Chief Counsel Of FDA, Jeffrey M. Senger, Joins Sidley Austin LLP
Posted on 10 Aug 2010 by LexisNexis Litigation Resource Community Staff

WASHINGTON, D.C. - Sidley Austin LLP has announced that Jeffrey M. Senger, former acting chief counsel and Deputy Chief Counsel of the Food and Drug Administration, has joined Sidley as a partner in the global food, drug and medical device regulatory... Read More