The QMN Weekly Bulletin

A planned, first-of-its-kind U.S. standard on supply chain risk management will include input from a handful of drugmakers to highlight the impact that compliance lapses have on supply chain security, says the chair of a newly formed industrywide panel developing the standard.

Amplivox, a UK subsidiary of Danish company William Demant, received a warning letter from the FDA following a December inspection of its Oxford manufacturing plant.

President Barack Obama signed the FDA Safety and Innovation Act, S. 3187, into law July 9, reauthorizing the Medical Device User Fee Act (MDUFA) and Prescription Drug User Fee Act, and creating new user fee programs for generic drugs and biosimilars.

Last year’s court ruling that sent four former Synthes executives to prison for clinical trial deaths represents an expansion of case law and a warning to other devicemakers, a legal expert says.

The FDA has handed Luitpold Pharmaceuticals a Complete Response Letter (CRL) on its NDA for Injectafer after a recent inspection raised concerns about the drugmaker's Shirley, N.Y. manufacturing facility.

Siemens Healthcare Diagnostics has received its second FDA warning letter this summer, following an inspection of the company’s Newark, Del., plant.

A&Z Pharmaceutical failed to adequately investigate unexplained discrepancies in drug products tied to compression-related troubles at the company’s Deer Park, N.Y., plant, a Form 483 states.

The FDA’s Cincinnati District Office issued a Form 483 to a maker of electroencephalogram application caps and related supplies due to missing validation and control procedures at its Eaton, Ohio, plant.