The QMN Weekly Bulletin

As medical devices become more complex and the FDA increases the effectiveness of its postmarketing surveillance, success in handling product recalls will become a key business activity for devicemakers, according to Kimber Richter, deputy director of medical affairs for the Center for Devices and Radiological Health’s (CDRH) Office of Compliance.

The European Medicines Agency’s (EMEA) public-release version of its new EudraGMP database will likely not include valuable information, according to Peter Smith, vice president of pharmaceutical compliance for Parexel Consulting.

Ten years since the FDA implemented the quality system regulation, a majority of devicemakers view design control requirements favorably, a recent survey finds.

AstraZeneca said that a news report stating the pharmaceutical giant plans to completely exit pharmaceutical manufacturing over the next 10 years is incorrect.

Medical device maker St. Jude Medical Inc. said it is adding up to 1,200 new employees in Puerto Rico over the next three years to work at a recently purchased plant.

Genzyme broke ground for a new $150 million expansion project at its Allston, Mass., plant expected to create 90 new jobs.

Parexel Consulting, a business unit of Parexel International and a leading global life sciences consultancy serving the bio/pharmaceutical and medical device industries, announced that it is strengthening its Good Manufacturing Practice (GMP) capabilities in Europe to help its global client base address complexities of European Union (EU) directives in areas such as manufacturing regulations, quality, and safety.

A member of an international crime ring which bought fake Viagra and drugs against baldness from factories in Asia before selling them on to unsuspecting customers at a huge profit has been jailed in Britain.

Microorganisms may soon be efficiently and inexpensively producing novel pharmaceutical compounds, such as flavonoids, that fight aging, cancer or obesity, as well as high-value chemicals, as the result of research being conducted by University at Buffalo researchers.