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Theqmnweeklybulletin

July 20, 2012

Vol. 4 No. 29

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Supplier Glass Vial Defects Prompt Warning on Hospira Cancer Drug

Hospira is looking into a supplier glass defect following consumer complaints and a Health Canada warning to physicians not to use three lots of its cancer treatment paclitaxel injection, 300 mg/50 mL. Read More

Drugmakers Brace for IT Changes, Costs Related to EU Pharmacovigilance Regs

Beginning this month, drugmakers and competent authorities must report all adverse drug reactions — not just serious ones — to the EU’s centralized EudraVigilance database. Read More

CBER Plan Aims to Speed AE Analysis, Reduce Phase III Failures

FDA’s Center for Biologics Evaluation and Research (CBER) hopes to speed studies of biologic adverse events within the next five years by using the FDA’s Mini-Sentinel postmarket surveillance pilot in partnership with other government agencies and private organizations. Read More

California Devicemaker Warned By FDA on Numerous GMP Lapses

An optical supplies manufacturer has received an FDA warning letter for nine violations, including complaint handling, device design and corrective and preventive action (CAPA) failures. Read More

Infant Breathing Device Recalled

CareFusion has initiated a Class 1 recall of its AirLife infant breathing circuits. Read More

Novartis’ Nebraska Plant Powering Up, But Remediation Pain Brings Income Hit

Production at Novartis’ Lincoln, Neb., OTC drug plant has begun to ramp up “line by line, product by product,” but six months of remediation has contributed to flat 2012 sales and a 5 percent drop in operating income compared with last year, company officials say. Read More

Warning Letter States Siemens Marketed Unapproved Diagnostic

Siemens Healthcare Diagnostics has come under FDA scrutiny after an inspection at its Tarrytown, N.Y., plant found the company was marketing a diagnostic test that had never been officially approved. Read More

Spanish API Maker Ercros Warned for GMP, Pest Problems

The FDA has warned Spanish industrial giant and active pharmaceutical ingredient (API) maker Ercros S.A. for good manufacturing practice (GMP) nonconformities, including various validation lapses and building disrepair that invites pests. Read More