The QMN Weekly Bulletin

Under the recently published amendments to the European Union’s (EU) revised medical device directives, manufacturers must include a description of how they monitor third-party contractors in review applications submitted to notifying bodies.

The FDA has ordered that active pharmaceutical ingredients (APIs) manufactured at a Kunshan Chemical & Pharmaceutical production facility be denied entry into the U.S. Kunshan is based in China.

The European Medicines Agency (EMEA) recommended the market reintroduction of Roche’s HIV treatment Viracept after the company recalled all batches of the drug due to a manufacturing error, but the firm does not anticipate sales of the product to reach previous levels as patients have since switched to other treatments, Roche told MQN.

Shire is taking the next step to build a large manufacturing facility in Lexington without any definitive agreement on tax incentives with either the town or the commonwealth.

Thermo Fisher Scientific, a maker of laboratory tools and materials, reports the company is expanding its presence in Utah.

Industry association AdvaMed is taking a proactive role — meeting with Chinese and U.S. healthcare officials — to ensure that medical devices and device components imported from China pose no risks to the U.S. public, AdvaMed said in a recent conference call.

After acquiring a local rival, a Swedish medical device company with its U.S. headquarters in Massachusetts plans to keep and expand the combined operation here.

Taiwan has decided to ask that a deadline be set for the signing of a contract on a build, own, operate (BOO) project for the production of flu vaccines in Taiwan with Dutch Pharmaceutical company Akzo Nobel, a Department of Health (DOH) source said.

The pharmaceuticals regulators of at least five states have asked around 800 large and medium drug makers to immediately withdraw the so-called “combination drugs,” which do not have central regulatory approval, from the domestic drugs market in India.