The QMN Weekly Bulletin

Manufacturers making a modification to an approved device in the U.S. have new guidance on how to submit the required 180-day supplements to their premarket approval applications (PMAs).

Lots of PriCara’s 25-microgram/hour Duragesic CII patches and Sandoz’s fentanyl patches are being voluntarily recalled in the U.S. due to a cut along one side of the drug reservoir.

A medical kit and tray maker received an FDA warning letter after it switched the size of safety pins in one of its circumcision trays.

Novavax Inc. is selling its Malvern, Pa., plant, which it said in October it would close, and rights to its Estrasorb estrogen treatment.

Drug company Watson Pharmaceuticals announced [this week] it will close three properties, including laboratories on West Street that employ about 60 people.

The multinational pharmaceutical firm GlaxoSmithKline [GSK] is to lay off 100 workers at its plant in Cork.

PDL BioPharma Inc. sold its Brooklyn Park, Minn., antibody manufacturing facility to Genmab A/S of Denmark, the latest asset-shedding move by the company.

Scientists at the Science and Technology Facilities Council (STFC) Rutherford Appleton Laboratory have developed an effective laser-based method for the characterization of the bulk chemical content of pharmaceutical capsules — without opening the capsules.