The QMN Weekly Bulletin

More than two years after withdrawing a final rule that would have exempted investigational drugs in Phase I testing from certain GMP regulations, the FDA is issuing a final rule to do just that.

The FDA has warned devicemaker Duro-Med Industries for several GMP violations related to its hot and cold compresses, including failure to investigate a complaint about a burned cornea.

The U.S. Pharmacopeia (USP) is urging manufacturers outside the U.S. to adopt a new monograph for levothyroxine sodium, which tightens potency specifications.

180 jobs are to go in Cork after pharmaceutical giant Pfizer announced it had failed to find a buyer for one of its five manufacturing facilities in Ireland.

Actavis Totowa, the U.S. headquarters of the Icelandic generic drugmaker, is contacting hospitals and pharmacies across the country to recall all the generic medicines made at its Little Ferry manufacturing plant.

US medical device company Abiomed is to open a new manufacturing facility in Athlone that it says will create 250 jobs over the next 18 months.

When a company decides to leave town, community leaders sometimes try to downplay the impact. But Affymetrix Inc. has been too important to the area's biotech industry for that.

A New Jersey pharmaceutical manufacturing and consulting firm is planning to build a $115 million facility in New Castle County, with the promise of bringing as many as 150 high-paying jobs to the state.

Pfizer Inc., the world's largest drugmaker, is coming to San Francisco's Mission Bay. The company will move about 100 employees — including the headquarters of its new Biotherapeutics and Bioinnovation Center — into a new structure in San Francisco's growing Mission Bay biotech development.