The QMN Weekly Bulletin

The FDA will delay reforms to its Office of Regulatory Affairs (ORA) until a working group completes its assessment of import safety, agency Commissioner Andrew von Eschenbach recently said.

Contact lens maker Crystal Reflections International’s change control procedure was unsigned and undated, and changes to documents were made via “Post-it” notes, the FDA said in a recent warning letter.

A new European Medicines Agency (EMEA) draft guideline details factors taken into consideration when the agency determines whether clinical studies are necessary to evaluate a biologic drug product after its manufacturing process has changed.

China has returned 272 heart pacemakers imported from the United States after they failed quality inspections, China’s top quality control agency announced on Monday.

The total gross industrial output value of China’s pharmaceutical industry will be as high as RMB 600 billion ($78.95 billion) this year, up 17.8 percent to 18.5 percent when compared with 2006, according to a report by the State Food and Drug Administration’s Southern Medicine Economic Research Institute.

BSD Medical announced the completion of the Food and Drug Administration’s (FDA) pre-approval audit for the PMA submission of the company’s BSD-2000 hyperthermia system, along with the completion of a routine Quality System (QS)/Good Manufacturing Practices (GMP) inspection.

Vice President Alhaji Aliu Mahama has expressed concern about the influx of counterfeit and sub-standard drugs into Ghana by international criminal gangs, under the guise of free trade.

Manufacturing workers at Smith & Nephew’s plant in Largo got the bad news recently in a PowerPoint presentation: Their jobs are headed to China.

Pfizer Inc. is breaking ground today on a $50 million expansion in Chesterfield that signals the increasing importance of biotech drugs to the struggling pharmaceutical giant.