The QMN Weekly Bulletin

House Democrats are questioning the FDA’s view that conducting preapproval inspections is a matter of policy rather than a statutory requirement.

Baxa failed to report two serious injury complaints to the FDA because the injuries were caused by user error.

Implantable medical devices such as pacemakers, drug pumps and implantable cardioverter defibrillators (ICDs) face hacking risks, which can threaten patient safety and privacy, a new study finds.

Batch pedigrees, obligatory product seals, mass serialization, mandatory audits and tighter requirements for the manufacture, import, export and transportation of medicinal products are among the legislative steps being considered by the European Commission to counter the growing threat of counterfeit drugs in the EU.

Alkermes Inc. said … it plans to cut about 150 jobs, or 18 percent of the Cambridge biotech’s workforce, … and shut down its Chelsea manufacturing plant after a partner decided to halt development of an inhalable form of insulin for diabetics.

Pfizer Inc. has notified the state Department of Labor that it will close its Groton Manufacturing Operations Site at Eastern Point Road and lay off the 80 manufacturing workers employed there.

The Hyderabad-based Natco Pharma Limited has informed that the U.S. Food and Drug Administration (U.S. FDA) has approved company’s active pharmaceutical ingredients (APIs) facility at Mekaguda in Mahaboobnagar district, Andhra Pradesh for production of some additional products.

China’s drug watchdog on Thursday urged its local bureaus to step up supervision and inspection on blood-thinner heparin production to ensure quality and safety.

An inspection at the Knoxville facility of Siemens Medical Solutions USA has resulted in a warning letter from the U.S. Food and Drug Administration.