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Theqmnweeklybulletin

Sept. 28, 2007

Vol. 1 No. 14

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Diagnostics Firm Warned for Product Mix-Ups

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

Final EMEA Guideline on Excipients Excludes Products in Development

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. Read More

Health Canada Outlines 2007-2012 Strategic Plan for Medical Devices

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. Read More

FDA Official Cites Lapse in Overseas Inspections

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. Read More

Singapore’s August Factory Output Surges 13.8 Percent

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. Read More

Plexus Plant in Asia Clears FDA Review

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. Read More

Wockhardt Signs MoU for Pharma SEZ in M’rashtra

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. Read More

SFDA Finishes Draft of Revised Medical Device Regulation

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. Read More

A Contract to Win

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