The QMN Weekly Bulletin

CDER plans to standardize REMS development to make the safety tools more effective and less burdensome for drugmakers.

The FDA handed a cardiac surgeon at Washington, D.C.-based Washington Hospital Center a warning letter for not having institutional review board (IRB) approval when recruiting some patients into a clinical trial.

The FDA will begin policing compliance with clinical trial submission requirements for ClinicalTrials.gov under a policy change at HHS.

Hospira is voluntarily recalling an infusion pump due to reports the device’s touch screen control panel may become unresponsive, according to a recent FDA bulletin.

The FDA has hit International Laboratories Canada with a warning letter for GMP violations related to supplier qualification and the company’s quality control unit.

Surgical staplers manufactured by Johnson & Johnson’s Ethicon division are the subject of a voluntary Class I recall.

Slow remediation of GMP problems at Novartis’ Lincoln, Neb., OTC drug plant has dashed hopes for a pre-2013 return to production, company officials say.

Establishing the right kind of verification process and bringing in human factor testing experts early in the development phase are key to successful device design, says industry guru Michael Hoffman.