Food and Drug Administration

ACC Actions

• FDA Network of Expert FAQs

  ACC Weighs in on FDA's Cigarette Warning Label Decision (4/13)

  International Consortium of Cardiovascular Registries Establishes Roadmap for Registry Collaboration (4/13)

  Physician Group Sign On Letter Opposing FDA Cigar Exemption (7/12)

  Joint Letter to House of Representatives Opposing FDA Cigar Exemption (6/12)  

  Joint Letter to Appropriators Opposing Efforts to Weaken FDA Authority to Regulate Tobacco Products (6/12)

  ACC Comments on Pre-Market Approval of Transcatheter Heart Valve (6/12)

  Joint Letter Supporting Sec. 908 of Senate User Fee Act (6/12)

  ACC Testifies Before FDA on ASD Closure Devices (5/12)

  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)

FDA Updates

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  FDA Approves New Lipid Lowering Combination Tablet (5/13)

  FDA Approves First-in-Class Therapy for Urgent Warfarin Reversal in Patients with Acute Major Bleeding (4/13)

  FDA Rejects Rivaroxaban for Treatment of ACS for the Second Time (3/13)

  FDA Investigation Does Not Find an Excess Bleeding Risk Associated With Use of Dabigatran (11/12)

  FDA Approves Expanded Indications for Transcatheter Heart Valve (10/12)

  FDA Statement on Fungal Meningitis Outbreak Includes Cardioplegic Solution Warning (10/12)

  FDA Warns of Possible Risk of Heart Failure in Patients Treated with Pramipexole (9/12)

  FDA Warns Against Use of Sildenafil in Pediatric Patients (8/12)

  FDA Approves Generic Version of Pioglitazone to Treat Type 2 Diabetes (8/12)

  FDA Releases Proposed Rule on Unique Device Identifier (7/12)

  FDA Approves Heart Valve Trial (6/12)

  FDA Rejects Use of Rivaroxaban for Treatment of ACS (5/12)

  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)

Related News

• FDA User Fee Bills Pass Both the House and Senate (5/12)
  New Study Questions FDA Medical Device Review Process (2/11)