The QMN Weekly Bulletin

Components used to make Biogen Idec’s multiple sclerosis drug Avonex were not consistently shown to be suitable for use, drawing a Form 483 for the company’s North Carolina plant.1

Drugmakers should have a structured plan for assessing evidence in an adverse reaction report, taking into account clinical relevance, quantitative strength of the association and other factors, according to a draft European Medicines Agency (EMA) guideline.

Thoratec, a California-based maker of heart disease-treating equipment, has received a Form 483 for failing to thoroughly investigate — and submit a timely MDR for — a complaint involving a patient death that may have resulted from a malfunction of one of its devices, a Form 483 states.

Studies of approved drugs that involve a different route of administration or dosage level that significantly increases the drug’s risks are not exempt from clinical trial investigational new drug (IND) regulations.

GlaxoSmithKline has recalled 10 lots — some 394,000 bottles — of its hypertension drug DynaCirc CR after quality and commingling issues at Novartis’ troubled Lincoln, Neb., plant, where it was produced.

Less than a year after approval and before the product could really get off the ground, the FDA has issued a MedWatch notice on a recall of The Medicines Company’s anticoagulant Argatroban injection because of visible particulates.

Devicemakers can expect quality system audits to include a review of their postmarket surveillance procedures, including plans for any required clinical follow-up studies, according to a new European Commission guideline.

Inadequate procedures, particularly corrective and preventive action (CAPA) failures, have earned Canada-based Intelligent Hospital Systems (IHS) an FDA warning letter.