The QMN Weekly Bulletin

The FDA expects to pilot a mobile version of the MedWatch reporting form on hand-held devices by the end of this year, one of several new software tools the agency is developing to improve postmarket monitoring of adverse events.

Drugmakers seeking approval for biologics trials in the EU must describe and justify their manufacturing processes and process controls, ideally with a flow chart of all steps, the European Medicines Agency (EMA) says.

The FDA is giving drugmakers some key advice for qualifying and auditing contract manufacturers: Start by requesting the same documents the agency wants to see when it begins an audit.

Onsite inspections of clinical investigators triggered by referrals experienced an upswing in 2011.

A bevy of documentation shortcomings led to a warning letter for Compumedics Germany.

Chinese-made drugs approved by the World Health Organization (WHO) are seven times more likely to be substandard, degraded or counterfeit than similar Indian-made drugs approved by the WHO, according to a new study.

Failure to report adverse events from a battery-operated toothbrush were among several observations in a Form 483 generated after a Jan. 9 to Feb. 13 inspection of Church & Dwight’s Princeton, N.J., facility.

Eighty percent of drugs consumed in the Middle East are currently imported, but governments across the region are trying to change that by boosting domestic manufacturing and joint ventures and licensing deals, according to Frost & Sullivan’s analysis of the Gulf Cooperation Council pharmaceutical market.