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.Read More

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. Read More

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.Read More

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. Read More

A bevvy of concerns about complaint handling and inventory led to an FDA warning letter for wheelchair-lift maker ThyssenKrupp Access Manufacturing.Read More

Amid ongoing efforts to address a previous FDA warning, Impax Laboratories has been hit with a fresh Form 483 after a general inspection unearthed additional quality issues at the company’s Hayward, Calif., facility, further complicating a growing ANDA backlog, the drugmaker says.Read More