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Theqmnweeklybulletin

Feb. 17, 2012

Vol. 4 No. 7

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Drugmakers Should Test Heparin Shipments, Audit Suppliers: FDA

The FDA is bolstering the heparin supply chain with a draft guidance telling drugmakers to test each incoming shipment of heparin for species origin and contaminants, and audit each of their heparin manufacturers and handlers. Read More

Lens Recall Spurs Cooper Class Action Suit, Focus on Poor Quality Controls

Cooper Companies failed to warn stockholders about quality problems leading up to its massive recall of Avaira Toric and Sphere lenses, and is now facing a class action lawsuit. Read More

Hamburg: Focus on Patients, Improve Recruitment

Trial sponsors can boost recruitment and improve their understanding of how drugs work in different groups by turning to patient-centered research and adaptive trial designs, FDA Commissioner Margaret Hamburg and other experts say. Read More

Drugmakers Lose Time, Money With Mistakes About CDER’s Policies

Too many drugmakers are left dealing with warning letters and complete response letters after finding they didn’t meet CDER’s expectations for drug trials or manufacturing. Read More

FDA, Roche Warn on Counterfeit Avastin Entering U.S. Via Unauthorized Supplier

Counterfeit versions of Genentech’s cancer drug Avastin are circulating in the U.S. supply chain after 19 practitioners bought the drug from an unauthorized foreign supplier, the FDA and the Swiss-owned drugmaker warn. Read More

FDA Takes Aim at Two Integra Units in Form 483s

Integra subsidiary Theken Spine was handed a Form 483 for failure to submit 11 of 35 complaints involving products made at its Akron, Ohio, facility. Read More

Tablet Turbulence at Novartis Plant Prompts Recall, New 483

A new Form 483 for Novartis Consumer Health’s Lincoln, Neb., facility cites a litany of manufacturing failures and instances of tablets gone wild, with products found in odd areas of the plant’s packaging line — GMP deficiencies that prompted a nationwide recall last month. Read More

Dressing Maker Warned for cGMP, Supplier Quality Shortcomings

A host of violations related to current good manufacturing practices (cGMPs), including failure to adequately validate packaging and sterilization processes, has landed PhotoMedex — a Montgomeryville, Pa.-based maker of burn and wound dressings — an FDA warning letter. Read More