The QMN Weekly Bulletin

While the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) supports the European Commission’s (EC) proposal to combat drug counterfeiting, it says certain requirements conflict with UK regulations.

Center for Drug Evaluation and Research (CDER) Director Janet Woodcock plans to refocus the center’s efforts on the FDA’s GMPs for the 21st Century initiative now that she is permanent director of the drugs center.

Baxter is refuting charges made last month by China’s State Food and Drug Administration (SFDA) that the company did not cooperate with Chinese inspectors during an audit of its heparin finished dose plant in New Jersey.

A Digitek class action lawsuit filed on the heels of April’s Digitek recall raises serious questions about the way the defective pills were made.

Ipca Laboratories has received approval from US Food and Drugs Administration to manufacture Propranolol Hydrochloride Tablets USP 10 mg, 20 mg, 40 mg, 60 mg and 80 mg for the US market.

Sunesis Pharmaceuticals Inc. said it plans to cut about 60 staff positions and refocus its business on its lead oncology product candidate.

Several domestic [Vietnamese] drug companies have begun to export their products, eyeing markets in Asia, Africa, Russia, the US and EU.

It has become increasingly clear to Americans within the last 12 months that foreign manufacturers need greater regulation.

President Umar Musa Yar'Adua has stated that for Nigeria to attain self sufficiency in drug production, generate employment and achieve vision 20-2020, indigenous pharmaceutical firms must expand their manufacturing capacity.