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ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration issued a new guidance Monday on indexing structured product labeling. The Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research will begin indexing structured product labeling in the product labeling for human drug and biologic products.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The transatlantic cooperation of the European Commission, the European Medicines Agency, and the US Food and Drug Administration was recognized at the Second Meeting of the Transatlantic Economic Council, held mid May in Brussels. The TEC is tasked with overseeing and accelerating government-to-government cooperation to advance economic integration between the United States and the European Union.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The Synthetic Organic Chemical Manufacturers Association is evaluating proposed legislation, The Climate Security Act of 2008 (S. 3036), which directs the Environmental Protection Agency to establish a program for decreasing greenhouse emissions.

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Report from: India

With rising drug deveopment costs and burdensome clinical trials, Indian-based firms are transferring their research departments to other entities in hopes of saving cash, mitigating risk, and ultimately, buying back the rewards.

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Letting the public inside the drug development process may increase their faith in what we do.

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Pharmaceutical Technology Europe

On 7–9 May I attended ERBI's Biopartnering Exchange in Cambridge (UK), an event that brought together national and international entrepreneurs, senior executives and industry experts of the biotechnology sector.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Last week, 2704 delegates representing 190 nations met in Geneva for the 61st World Health Assembly to set a global course for tackling new as well as longstanding threats to public health worldwide. The assembly?s biggest breakthrough focused on adopting a resolution that encourages research and development (R&D) as well as access to medicines for people living in developing countries, according to a World Health Organization (WHO) release.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Senate approved a measure (HR 2642) that would provide the US Food and Drug Administration with $275 million in additional funding under a supplemental appropriations bill. The measure now goes before the House.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade association representing European pharmaceutical manufacturers, issued recommendations to the public consultation launched in March by the European Commission's proposed drug anticounterfeiting measures. EFPIA's proposal includes a ban on drug repackaging.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The World Health Organization's World Health Assembly is holding its 61st annual session this week to discuss a number of public health issues, many of which are tied directly to pharmaceutical manufacturing.