The QMN Weekly Bulletin

The FDA is planning to reorganize its Office of Regulatory Affairs (ORA), including creating new offices and reorganizing others, as it takes steps to dissolve cumbersome domestic and international distinctions and to keep up with increasingly global operations.

The FDA is warning a pharmacy in Vancouver for continuing to sell its unapproved clobazam to U.S. patients despite the agency’s approval of Lundbeck’s Onfi in 2011.

CDER’s proposed new Office of Pharmaceutical Quality (OPQ) is needed to promote good manufacturing practice (GMP) standards in the preapproval setting — standardizing GMP assessments throughout a drug’s life cycle.

The outlook for companies making implantable cardiac defibrillators (ICDs) may have just gotten a bit brighter, as the U.S. Department of Justice (DoJ) took a significant step toward closing out its investigation of off-label use of ICDs in U.S. hospitals.

Jazz Pharmaceuticals received an FDA warning letter for overstating the benefits and minimizing or omitting the risks of its schizophrenia drug FazaClo in a patient brochure.

Sovereign Pharmaceuticals’ blend uniformity tests and batch failure investigations fall short of the company’s written procedures, an FDA Form 483 states.

Telemetry company ScottCare has corrected all violations found during a site inspection earlier this year, earning an Aug. 13 closeout letter from the FDA’s Cincinnati District Office.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has urged Pacira Pharmaceuticals’ cancer drug DepoCyte be recalled in certain EU countries, citing “manufacturing deficiencies” found at the company’s San Diego, Calif., facility.