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ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration plans to begin collecting information for its Sentinel Initiative, according to a Sept. 4 Federal Register announcement.

ePT--the Electronic Newsletter of Pharmaceutical Technology

In move designed to increase its position in North America, Dainippon Sumitomo Pharma (DSP, Osaka, Japan) has agreed to acquire the specialty pharmaceutical company Sepracor (Marlborough, MA) for $2.6 billion.

Sanofi aventis has finished implementing Lanner's process simulation software into one of its major UK sites following a successful Phase I implementation in which the company made more than £1 million in inventory cost savings in 6 months.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Implementing Europe's Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) program, will require a massive increase in animal testing and cost six times more than previously estimated.

ePT--the Electronic Newsletter of Pharmaceutical Technology

An H1N1 vaccine developed by biopharmaceutical company Sinovac Biotech (Beijing, China) has passed the experts evaluation organized by the Chinese State Food and Drug Administration (SFDA) and the company is expected to obtain a production license before the week's end.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Later this month, Dr. Barbara Jentges, the managing director at PhACT GmbH, a regulatory consulting and training firm based in Duggingen, Switzerland, will be speaking at the 2nd Vetter Drug Management Leadership Conference in Germany.

Of Audits and Gunk

Thanks to their keen observations, these auditors reveal the true culprits of deviations.

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A Brave New Path for Pharma

Personalized medicine and integrated healthcare delivery require new business and pricing models. This article contains bonus online-exclusive material.

Report From: Brazil

Designated as a "pharmerging market," Brazil is revamping its pricing models.

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Pharmaceutical Technology Europe

Merger, union, alliance, partnership, collaboration: five words that ultimately suggest the strengthening of something.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Eastern Europe's pharmaceutical market is forecast to grow at a CAGR of more than 10% to be worth more than $41 billion by 2014, according to a report from companiesandmarkets.com.