The QMN Weekly Bulletin

Louisville APL Diagnostics failed to consult the FDA about several product recalls, according to a recent warning letter.

The European Medicines Agency’s (EMEA) final guideline on data submission requirements for excipients in marketing authorization applications does not apply to drug products currently in the clinical research stages of development.

Health Canada has announced a five-year plan for the Medical Devices Program (MDP) that includes new measures to increase risk management of clinical trials and postmarket activities, punish firms that fail to comply with MDP regulations and stem the distribution and sale of counterfeit devices.

The Food and Drug Administration acknowledged it cannot come close to conducting regular safety inspections of overseas plants that make prescription medicines and bulk drug ingredients imported into the United States.

Singapore’s industrial production rose 13.8 percent in August from a year ago, boosted by strong contributions from the biomedical sector, the government said.

Plexus said Thursday that it has received the approval of the U.S. Food and Drug Administration to manufacture class III medical devices at its plant in Malaysia.

Pharmaceutical and biotechnology major Wockhardt signed a memorandum of understanding (MoU) with Maharashtra Industrial Development Corporation (MIDC) to establish a special economic zone (SEZ) in Aurangabad, India.

China’s food, drug and medical device safety watchdog, the State Food and Drug Administration (SFDA) announced that it has completed the draft version of the Revised Regulations for the Supervision and Administration of Medical Devices, and will welcome suggestions from the public.

Shasun Chemicals has gained size with the acquisition of Rhodia Pharma and nearly half of its revenues will come from contract manufacturing.