Food and Drug Administration

ACC Actions

• ACC Comments Address FDA Proposal to Remove Prescription Requirements for Certain Medications (5/12)

  ACC Letter to Energy and Commerce on the User Fee Acts (5/12)

  ACC Comments on Safety of Atrial Septal Defect Occlusion Devices (4/12)

  ACC Comments on Proposed Medical Device User Fee Act Reauthorization Performance Goals and Procedures (4/12)

  Joint Letter on Pediatric Medical Device Consortia Funding (4/12)

  ACC Comments on Draft 2013-2017 PDUFA Reauthorization Performance Goals and Procedures (10/11)

  ACC Participates in FDA Advisory Committee Hearing on SAPIEN Transcatheter Heart Valve (7/11)

  ACC Comments on Humanitarian Device Exemption for EXCOR Pediatric Ventricular Assist Device (7/11)

  ACC Comments to Energy and Commerce Committee on Medical Device Regulation (2/11)

FDA Updates

• Get the latest FDA Updates

  FDA Reviewing Results of New Study Linking Azithromycin With Increased Risk of CV Death  (5/12)

  FDA Approves Generic Versions of Clopidogrel Bisulfate (5/12)

  FDA Extends Review of New Obesity Drug (Qnexa) (4/12)  

  FDA Issues Recall for HeartMate II Heart Pump (4/12)

  FDA Issues New Drug Safety Recommendations for Celexa (3/12)

  FDA Issues Label Change for Statins (2/12)

  FDA Issues Safety Warning and Label Changes for Dronedarone (12/11)

  FDA Approves Berlin Heart's EXCOR Pediatric System (12/11)

  FDA Evaluating Post-Market Reports of Serious Bleeding Events With Dabigatran (12/11)

  FDA Removes Breast Cancer Indication from Avastin Label (11/11)

  FDA Approves Rivaroxaban to Reduce Risk of Stroke in AFib (11/11)

  FDA Approves SAPIEN Transcatheter Heart Valve (11/11)

  Imaging Alert: Bracco Issues Update Regarding CardioGen-82 Safety Investigation (9/11)

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Related News

• New Study Questions FDA Medical Device Review Process (2/11)