The QMN Weekly Bulletin

Implantable cardioverter defibrillators (ICDs) are life-saving devices whose failures can cause patient deaths; therefore, the communication of these failures to healthcare professionals requires a “specialized approach,” the FDA says in a recent guidance.

The FDA is recommending that producers of biological drug products engaged in shared manufacturing agreements submit biologic license applications (BLAs) and supplements concurrently or risk a refuse-to-file action, according to a recent draft guidance.

A U.S. subsidiary of the notifying body National Standards Authority of Ireland (NSAI) is refocusing its certification efforts by offering device manufacturers a program where they can obtain a CE mark or Canadian Medical Devices Conformity Assessment System (CMDCAS) certification within 60 to 90 days, Chris Morrell, vice president of NSAI’s U.S. division, told MQN.

The high cost antiretroviral (ARV) drugs and inadequate control mechanisms in Zimbabwe are driving a flourishing trade in fake ARVs by unlicensed dealers, activists have warned.

Indian pharmaceutical companies exporting medicines worth $1 billion to at least a dozen countries like Brazil, Mexico, China and Germany are finding non-tariff barriers, in the form of discriminatory treatments, hampering their export growth prospects.

Singapore’s factory output rose by 25 percent in July, compared to the previous month, on the strength of higher biomedical manufacturing output – the sharpest rise in almost three years.

MedImmune has opened a pilot lab in Gaithersburg, Md., that boosts the company’s production capacity by four times.

British pharmaceutical giant Shire warned that plans for a major drug-manufacturing complex in Boston’s suburbs could be in jeopardy unless Beacon Hill passes a trumpeted, $1 billion incentive package for the life sciences industry.

A pharmaceutical products subsidiary of Sigma-Aldrich is planning a $4.5 million expansion of its chemical manufacturing facility in Madison, Wis.