Entries from HEALTH LAW SECTION BLOG tagged with 'China'

In the spotlight: FDA key initiatives

Today's FDA webpage show key initatives in their 'Spotlight' focus. This provides a nice overview of what is happening here in recent history and links to the respective website that focuses on each initiative. Through specially targeted initiatives, FDA intensifies...

FDA /CDERWarning Letters 2008-Bioresearch monitoring program

For purposes of thinking about trends, I found it interesting to take a look at the last 6 months of FDA/CDER Warning Letters resulting from inspections in regard to its Bioresearch Monitoring Program. The Warning Letters show recent and...

How do we know? Reported Trials of China, RCTs, the CONSORT Statement

A recent "Trials" paper (authors from China, UK ) [critically evaluates] RCTs conducted in China based on studies published in 2004... to describe their general characteristics, evaluate the quality of their reporting and evaluate their conduct where adequately reported.(1)...

"FDA Takes Next Step in Establishing Overseas Presence"

Here is some interesting news from FDA's email news service (3/14/08): ... an important development, the FDA has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the...

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