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March 21, 2008

Vol. 2 No. 12

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Congress Hammers FDA on Preapproval Inspections Policy

House Democrats are questioning the FDA’s view that conducting preapproval inspections is a matter of policy rather than a statutory requirement. Read More

Baxa Warned for Not Reporting Adverse Events to FDA

Baxa failed to report two serious injury complaints to the FDA because the injuries were caused by user error. Read More

Implanted Devices Can Be Hacked, Manufacturers ‘Can Do Better’

Implantable medical devices such as pacemakers, drug pumps and implantable cardioverter defibrillators (ICDs) face hacking risks, which can threaten patient safety and privacy, a new study finds. Read More

Commission Sets Out Its Stall on Anticounterfeiting Measures

Batch pedigrees, obligatory product seals, mass serialization, mandatory audits and tighter requirements for the manufacture, import, export and transportation of medicinal products are among the legislative steps being considered by the European Commission to counter the growing threat of counterfeit drugs in the EU. Read More

Alkermes to Trim 150 Jobs, Close Plant

Alkermes Inc. said … it plans to cut about 150 jobs, or 18 percent of the Cambridge biotech’s workforce, … and shut down its Chelsea manufacturing plant after a partner decided to halt development of an inhalable form of insulin for diabetics. Read More

Pfizer to Close Its Groton Manufacturing Site

Pfizer Inc. has notified the state Department of Labor that it will close its Groton Manufacturing Operations Site at Eastern Point Road and lay off the 80 manufacturing workers employed there. Read More

Natco Pharma Gets Nod for API Facility

The Hyderabad-based Natco Pharma Limited has informed that the U.S. Food and Drug Administration (U.S. FDA) has approved company’s active pharmaceutical ingredients (APIs) facility at Mekaguda in Mahaboobnagar district, Andhra Pradesh for production of some additional products. Read More

China Urges Enhanced Quality Control Over Heparin Production

China’s drug watchdog on Thursday urged its local bureaus to step up supervision and inspection on blood-thinner heparin production to ensure quality and safety. Read More

FDA Sends Warning Letter to Siemens Medical Solutions

An inspection at the Knoxville facility of Siemens Medical Solutions USA has resulted in a warning letter from the U.S. Food and Drug Administration. Read More