The QMN Weekly Bulletin

The FDA is implementing specialized training courses instructing agency inspectors on how to identify data integrity and fraud issues that have surfaced within the last two years.

Under the reauthorized Medical Device User Fee Modernization Act, the FDA will incorporate voluntarily submitted audit reports from devicemakers into its risk-based inspections program.

The FDA’s Office of Biotechnology Products (OBP) plans to begin a quality by design (QbD) pilot program soon, Helen Winkle, director of the Office of Pharmaceutical Science (OPS), said at the Parenteral Drug Association (PDA)/FDA’s 2007 Joint Regulatory Conference.

GlaxoSmithKline, Europe’s largest pharmaceutical company, unveiled a £1.5 billion restructuring drive designed to restore competitivness by closing plants, outsourcing manufacturing activities and cutting an unspecified number of jobs.

Arrow International, a new Teleflex subsidiary, has received a warning letter from U.S. drug regulators over its quality control measures.

Recent scientific advances and increased vaccine manufacturing capacity have prompted experts to increase their projections of how many pandemic influenza vaccine courses can be made available in the coming years.

Exact Sciences reports it has received a warning letter from the U.S. Food and Drug Administration concerning its DNA-based test for colon cancer.

Working under U.S. Environmental Protection Agency (EPA) grants of more than $200,000, Rowan University’s College of Engineering (Glassboro, N.J.) is expanding its work in “green engineering” with several regional pharmaceutical companies.

Chiu Technical was cited for systemwide deficiencies in its quality system (QS) relating to its Transilluminator Model BFO-150 device.