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Theqmnweeklybulletin

April 13, 2012

Vol. 4 No. 15

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FDA Rule Tweak Touts Use of Automated Systems for Cut Labeling

The increased use of automated control systems for cut labeling can reduce the risk of human error during the packaging process, the FDA says in a regulatory tweak that allows drugmakers greater flexibility in meeting manufacturing requirements. Read More

J&J Risperdal Settlement Snag Could Signal DOJ Deal Stance

A reported snag in settlement talks between federal prosecutors and Johnson & Johnson (J&J) over off-label marketing could signal the government wants to standardize its approach to prosecuting such allegations. Read More

Ranbaxy Forfeits Exclusivity for Three ANDAs Under Consent Decree

The FDA’s consent decree for Ranbaxy requires third-party audits of four facilities and it can be expanded to other plants if future inspections reveal compliance or data integrity issues, making it “unprecedented in scope,” the Department of Justice (DOJ) says. Read More

REMS, Postmarket Studies Come With Affymax, Takeda Anemia Drug Approval

The FDA granted approval to Affymax and Takeda’s once-monthly anemia treatment Omontys, but has loaded the companies with postmarketing requirements, including two safety studies and a risk evaluation and mitigation strategy (REMS). Read More

Hi-Tech Handed 483 for Deficient Dust Control

A seven-observation Form 483 handed to Hi-Tech Phamacal cites deficient dust control at the contract manufacturer’s Amityville, N.Y., facility. Read More

Maker of Blood Pressure Monitors Gets Warning for Quality Deficiencies

German devicemaker I.E.M. was hit with a warning letter after FDA investigators found shortcomings with medical device report (MDR) procedures and an array of quality “nonconformities” during a recent inspection of the company’s Stolberg, Germany, facility. Read More

FDA Restricts IRB Following Two Failed Inspections

The FDA has halted approval of new trials and enrollment in ongoing studies reviewed by the investigational review board (IRB) BioMed after two negative assessments of the board’s work. Read More

Software Firm Must Seek PMA, FDA Warning Letter States

The FDA has escalated a long-simmering dispute with Israeli-owned software developer NeuroTrax about the proper classification of its MindStreams cognitive health assessment tool, telling the company in a warning letter it must seek Class III status or halt marketing the product. Read More