WXYZ Detroit, November 5, 2014. The 7 Investigators obtained records from the Food and Drug Administration (FDA) showing that the original manufacturer of a permanent birth control device, Essure, knew patients were being harmed by the device more than a decade ago.
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Pfizer Loses a Bet On Removing Serious Warnings From Its Chantix Pill
The Wall Street Journal, October 17, 2014. In a setback for Pfizer, an FDA advisory panel yesterday voted overwhelmingly to maintain the most serious warnings on its Chantix smoking cessation pill.
Read More »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.
Read More »Antibiotic Resistance: Will Policymakers Resist Effective Strategies?
AAAS, October 14, 2014. One of the most pressing scientific issues facing Congress today is the risk that antibiotic resistance presents to human health. Unfortunately, there is an enormous gap between what the science tells us is needed and the Congressional approach.
Read More »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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