The QMN Weekly Bulletin

Pharmaceutical companies should be developing the capabilities to submit common technical document (CTD) applications electronically, Gary Buehler, director of the FDA’s Office of Generic Drugs (OGD), said.

The FDA needs to increase inspections and ensure the safety of imported products over their life cycles to prevent counterfeit and substandard drugs from entering the U.S. drug supply chain, witnesses and lawmakers said during a House Subcommittee on Health hearing last month.

North American Medical’s Accu-Spina back-pain/spinal-care devices are misbranded because the firm failed to appropriately investigate product complaints, according to a March 2 warning letter that was posted on the FDA’s website in September.

Amgen said it canceled plans for a $1-billion manufacturing plant in Ireland and would eliminate all 75 company jobs in the country.

Johnson & Johnson’s Independence Technology unit has renewed its long term contract assembly agreement with Creative Technology Services to provide assembly services for the iBOT 4000 Mobility System, a multi-functional mobility device.

Ranbaxy Laboratories, India’s largest drug maker, is planning to set up a joint venture in China to manufacture active pharmaceutical ingredients (APIs) used in drug manufacturing.

The next few years are expected to be lucrative ones for OEMs (Original Equipment Manufacturers) and contract manufacturer companies processing raw materials for medical device companies — especially in niche areas and among OEMs that offer flexibility to move with market changes.

Philippine President Gloria Macapagal Arroyo invited Indian pharmaceutical companies to set up manufacturing units in her country to provide medicines to the poor at affordable prices.

Plexus, a contract manufacturer of electronics products, has announced that one of its Penang, Malaysia facilities has received approval from the Food and Drug Administration (FDA), through its pre-market approval (PMA) supplement evaluation process, to manufacture class III finished devices for a large tier-one medical OEM. This approval follows an on-site audit in Penang by the FDA.