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Theqmnweeklybulletin

Oct. 12, 2007

Vol. 1 No. 16

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FDA Plans Draft Guidance Reducing Manufacturing Supplements

The FDA will no longer accept submissions for approximately 50 types of manufacturing supplements, according to a draft guidance the agency plans to release in the next few months, Helen Winkle, director of the Center for Drug Evaluation and Research’s Office of Pharmaceutical Science, said. Read More

Expert: Update Risk Management Systems to ISO 14971:2007

The risk management process, as spelled out in ISO 14971:2007, “will go a long way to prevent” errors in medical device design and manufacture, Barrett Craner, director of quality assurance for Lipid Science, said at a recent FDAnews audioconference. Read More

PDUFA Directs HHS to Develop Electronic Track-and-Trace Standards

Under legislation President Bush signed into law Sept. 27 reauthorizing the Prescription Drug User Fee Act (PDUFA), HHS is tasked with developing a standard numerical identifier for tracking drugs in the supply chain. Read More

Guangdong Revokes Licenses of Medical Device Manufacturers

The Guangdong Provincial Food and Drug Administration announced recently it has revoked the licenses of 67 medical device manufacturers and 274 medical device distributors. Read More

TeraView Buoyed by FDA Study in U.S. on Power of Tablet Imaging

Imaging specialist, TeraView has received a massive boost in the form of the publication of a new study by U.S. drug regulator, the Food and Drug and Administration. Read More

German Drugs Firm Cuts 220 Jobs

A leading pharmaceutical company has announced it is cutting 220 jobs, as part of a phased closure of its manufacturing plant in Berkshire. Read More

FDA Warns Medical Mattress Company

SCM Technologies failed to review 37 complaints over the course of a year from one of its rental customers, the FDA said in a recent warning letter to the firm. Read More

Long-Read-Range RFID Inlays Come in Compact Form

Omron RFID has unveiled Scorpion, the latest addition to its UHF EPC Gen2 family of RFID inlays, which is designed to seize the growing section of the RFID tag market that demands long read range in a compact form factor. Read More

PacificGMP Announces Agreement With BD Biosciences for Cell Banking and cGMP Antibody Manufacturing

PacificGMP, a contract manufacturing organization specializing in the development and manufacturing of biologics through single-use bioprocessing components, announced that it has signed an agreement with BD Biosciences, a segment of BD (Becton, Dickinson and Company), whereby PacificGMP will generate and provide storage for master and working cell banks and perform antibody manufacturing for BD Biosciences. Read More