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Feb. 22, 2008

Vol. 2 No. 8

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FDA Provides Guidance on Review of Manufacturing Information in PMAs

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). Read More

Damaged Pain Patches Recalled

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. Read More

FDA Pins Warning Letter on Medical Action Industries

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. Read More

Novavax to Sell Area Plant, Product to Graceway

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

Watson Pharmaceuticals to Close Three Sites

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

GSK to Shed 100 Jobs in Cork

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

PDL BioPharma Sells Minnesota Facility for $240 Million

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. Read More

New Laser Technique Identifies Pharmaceutical Capsule Content

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. Read More