The QMN Weekly Bulletin

With the FDA pushing drugmakers to put senior managers in charge of quality systems, companies’ top brass should expect to face scrutiny during inspections, agency officials say.

MEAS US, a subsidiary of Measurement Specialties based in Dayton, Ohio, failed to submit a premarket notification to the FDA for three medical devices it modified, a Form 483 states.

The European Medicines Agency (EMA) is seeking stakeholder input on the development of toxicological guidance for use in identifying the level of risk associated with making different drug products using shared facilities.

Irish drugmaker Shire has filed an application with U.S. and European regulators to produce its Gaucher disease drug at a new manufacturing site in Massachusetts, saying the move will give it flexibility to meet global demand for treatments of rare diseases.

Switzerland-based Ferring Pharmaceuticals today announced the purchase of a 25-acre site at 100 Interpace Parkway in Parsippany, N.J.

Coldstream Laboratories, a provider of drug product research and manufacturing services, has named Dr. Vickie Hall as Vice President of Manufacturing.

Sri Lanka has begun preliminary work on the country’s first pharmaceutical manufacturing zone.

Efforts to sell an insolvent pharmaceutical manufacturing plant in North Sydney have gone back to the drawing board.

Dr Reddy’s Laboratories has requested the government denotify its Special Economic Zone (SEZ) at Medak in Andhra Pradesh, India, said a top company official.