Chantix Citizen Petition

October 8, 2014. Five leading nonprofit consumer, research and medical organizations identified below petition the Food and Drug Administration (FDA) pursuant to the Food, Drug, and Cosmetic Act 21 USC 352, 505(o)(4), and 21 CFR 10.30 to take action to improve the safety information included in the label for CHANTIX® (varenicline) tablets , a smoking cessation aid approved under NDA 021-928.

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NCHR Testimony at FDA Advisory Panel on the WATCHMAN™ Left Atrial Appendage Closure Device

October 8, 2014. In summary, patients implanted with the device are at increased risk for ischemic stroke. Methodological problems make it difficult to assess if the device reduces hemorrhagic strokes. The decrease in major bleeding events after 6 months is negated by the increased major bleeding events due to surgery. The device is inferior to warfarin for 2 of the 3 primary endpoints identified by the sponsor and the FDA as signifying success.

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Comments on the Proposed Rule, “Medical Device Classification Procedures”

September 22, 2014. The Food and Drug Administration (FDA) is “proposing changes to the definition of class III to provide greater clarity regarding which devices fall within this class, and to improve transparency and predictability in device classification and reclassification decisions.” We commend the FDA for seeking clarity but we have grave concerns about the ways that the proposed rule weakens current definitions of class III devices.

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Comments on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices

August 25, 2014. With this draft guidance, the FDA is notifying manufacturers and others that it “does not intend to enforce compliance with regulatory controls that apply to” medical device data systems (MDDS), medical image storage devices, and medical image communications devices. The FDA has stated it is using its enforcement discretion on these devices because of “the low risk they pose to patients and the importance they play in advancing digital health.” We strongly disagree.

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