The QMN Weekly Bulletin

International cooperation between regulators is “taking off” — a trend that could limit the amount of duplicate inspections drugmakers face, a top CDER official says.

Devicemakers wishing to establish a full online presence must take special care to ensure their use of social media doesn’t throw them out of compliance with FDA promotional speech regulations, Edward Basile, with the consulting firm King & Spalding, told a recent session of the FDA/Xavier University MedCon conference here.

Access to electronic trial records systems must be limited to authorized, trained individuals who have unique passwords, an FDA official advises clinical research sites.

The FDA and international regulators must establish a much more collaborative framework in order to ensure the safety of the world’s drug supply chains, FDA Commissioner Margaret Hamburg says.

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.

Hospira is looking into a supplier glass defect following consumer complaints and a Health Canada warning to physicians not to use three lots of its cancer treatment paclitaxel injection, 300 mg/50 mL.

A review of several corrective and preventive action (CAPA) forms at Aqueduct Medical’s San Francisco facility revealed inadequate CAPA validation and follow-up, a recent Form 483 states.

Citra Labs, a maker of injectable anticoagulants, received a lengthy, 28-observation Form 483 noting various visual inspection shortfalls, including a lack of a rejection limit for glass particles.