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News Roundup: FDA, EMA Extend License for Aptiv Solutions

Articles: The 505(b)(2) NDA: Leveraging Other People’s Data

Blog Posts: Still Questions to Answer on Data Transparency

Marketplace: Marketplace

	FDA, EMA Extend Licenses for Aptiv Solutions for Dose Finding Analysis
	EMA, FDA Announces Joint Information Sharing Initiative on Generics
	EMA To Discuss Clinical Trial Data Access Plan in March
	TOPRA Announces Regulatory Excellence Award Winners

	The 505(b)(2) NDA: Leveraging Other People’s Data
	Sunshine Reporting Raises Concerns
	GCP Future: Looking Ahead to the Next 20 Years

	Still Questions to Answer on Data Transparency
	EMA Reflection Paper on Risk Based Quality Management in Trials

Clinical Data Disclosure and Transparency

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CHINA REPORT
China is the third largest pharmaceutical market in the world and will become the second largest ahead of Japan by 2015. Everything you need to know to do business in the country; key economic sector data and exclusive interviews from regional leaders. Read more

Lisa Henderson
Editor in Chief lhenderson@advanstar.com

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