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FDA’s Globalization Strategy Needs To Be More Aggressive, Sen. Brown Suggests

 
• By Derrick Gingery

The Ohio Democrat says the agency has to come up with a more creative way to deal with globalization problems than ask for additional funding to put more inspectors in China.

FDA Commissioner Margaret Hamburg was forced to defend her globalization policies, particularly in dealing with inspections of China manufacturing facilities, amid a Senator’s assertion that the agency could be more aggressive.

During an April 19 Senate Appropriations subcommittee hearing reviewing FDA’s FY 2013 budget request, Sen. Sherrod Brown, D-Ohio, asked, in...

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More from United States

More from North America

Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By Dean Rudge

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 
• By Michael McCaughan

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.

Will US FDA’s Leadership Rediscover The Value Of Advisory Committees?

 
• By Michael McCaughan

After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served by hearing from an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.