The QMN Weekly Bulletin

Sonic Innovations is taking a more conservative view of FDA regulations on reportable events after getting an FDA Form 483 for lapses in complaint handling and reporting procedures.

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, from consulting firm King & Spalding, told a recent session of the FDA/Xavier University MedCon.

Trial sponsors should notify the FDA about all adverse events brought to their attention by data monitoring committees (DMC), regardless of whether the safety issue is “serious” or not, according to new guidance.

As fallout from the defective PIP breast implant imbroglio continues, a European Parliament health committee is calling for tough new regulatory controls, including the creation of a premarket authorization system for certain categories of medical devices — an idea that brought immediate kickback from industry.

Draft International Conference on Harmonisation (ICH) guidance set for release in June will tighten regulatory controls on metal impurities in finished drug products, but drugmakers should begin analyzing planned and marketed products now, a Pfizer official urges.

The FDA’s recently deployed computer system that ranks imports according to risk was praised in a new government report, but a former agency official says it’s essentially stuck in neutral, citing the report’s chiding remarks about FDA sluggishness in integrating its legacy IT systems.

Federal authorities have arrested 11 South Florida men in connection to multi-million dollar drug thefts at the warehouses of Eli Lilly in Connecticut, GlaxoSmithKline (GSK) in Virginia and others.

The FDA may need to better match its regulations with those of key trading partners, a move that could benefit the increasingly global device industry, thanks to a new executive order (EO), 13609, signed by President Barack Obama May 2.