House GOP Proposes Changes for NIH, FDA

The Baltimore Sun, January 27, 2015. House Republicans are considering significant changes to the way billions of dollars in National Institutes of Health grants are awarded to research institutions under a proposal intended to speed medical breakthroughs.

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Is Early Stage Medical Device Development Going Overseas?

Wolters Kluwer Law & Health Blog, October 15, 2014. Even though the FDA has recently proposed a new program to provide earlier market access to high-risk medical devices, FDA Commissioner Margaret Hamburg nevertheless came under fire for the agency being too slow to approve medical devices at the annual conference of the Advanced Medical Technology Association (AdvaMed) in Chicago.

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Safety Advocates Seek Stronger Warnings On Chantix

Associated Press, October 8, 2014. Public safety advocates are asking the federal government to strengthen warnings on Pfizer’s anti-smoking drug Chantix, even as the drug maker prepares to argue that a bold-letter warning about psychiatric problems should be removed from the medicine’s label.

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