Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more
In Brief - In both the United States and abroad, food and drug regulatory and enforcement agencies are increasing current Good Manufacturing Practices enforcement, including criminal sanctions....more
In This Issue: - Tools of the Trade: BP Case Shows Advantage of Pretrial Motions - Increased cGMP Enforcement has Gone International: South Korean Action Against Johnson & Johnson Serves as Warning - DoD...more