The QMN Weekly Bulletin

The FDA and HHS may need to think twice before taking enforcement actions that could lead to drug shortages.

Canadian generic giant Apotex is suing the U.S. government, saying the FDA’s 2009 import ban on two of its Ontario plants “decimated” its U.S. business and violated the North American Free Trade Agreement (NAFTA).

A bevy of generic manufacturers have launched or plan to launch generic versions of AstraZeneca’s blockbuster antipsychotic Seroquel in the same week a federal judge dismissed the drugmaker’s attempts to block competition.

Swiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials.

Lucero Medical, an Ohio-based maker of vertebral body replacement devices, has been warned for lacking a slew of basic manufacturing procedures and for various 510(k) clearance violations.

Thoratec is voluntarily recalling lots of its HeartMate II Left Ventricular Assist System after receiving multiple reports of product parts falling off during x-rays and surgeries, the FDA says.

Drug regulators continue to find counterfeit Avastin in the U.S., with the product this time impersonating Genentech’s Turkish version of the cancer drug.

China’s State Food and Drug Administration (SFDA) has launched a four-month nationwide field program aimed at routing out businesses that provide inferior and counterfeit drugs.