The QMN Weekly Bulletin

Boston Scientific’s effort to improve its quality systems (QS) may differentiate it from competitors in the long run, Chief Operating Officer (COO) Paul LaViolette said during an investment conference.

Recalls for products regulated by the FDA’s Center for Drug Evaluation and Research (CDER) were up 170 percent in fiscal 2007, according to data released by the agency.

The Center for Devices and Radiological Health (CDRH) is in the planning stages for a network that will focus on problems with medical devices used in the home.

Singapore’ industrial output fell 2.8 percent in September from a year earlier mainly due to a dip in pharmaceuticals production, the government said.

While foreign companies now make as much as 80 percent of all ingredients used by American drug makers, the FDA performs fewer and less rigorous inspections abroad.

Novartis is expanding its already ambitious investment program in Singapore.

The Saudi Food and Drug Authority is preparing to launch a national registry for medical devices and in vitro diagnostic products in an effort to measure industry’s readiness for regulatory and monitoring controls.

Pharmaxis announced moves to expand its manufacturing capacity with the signing of an agreement for the construction of a new state of the art facility at Frenchs Forest, Sydney.

Akorn and Serum Institute of India, a privately-held worldwide leader in vaccines and the world’s largest manufacturer of Measles and Diphtheria Tetanus Pertussis vaccines, announced the signing of an Exclusive Memorandum of Understanding with an intent to commercialize six vaccines for the U.S. market.