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GXPNews.com - FDA News and Announcements - March 30, 2009 - April 03, 2009
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Center for Drug Evaluation &
Research (CDER) News

 Center for Biologics Evaluation
& Research (CBER) 		Center for Device &
Radiological Health (CDRH) 		Federal Register - Meetings, Notices, &  Rule Changes
April 3, 2009

April 2, 2009

April 1, 2009

March 31, 2009

March 30, 2009

  • New and Generic Drug Approvals
    • Axert (almotriptan malate) Tablets, Ortho-McNeil Pharmaceutical, Inc., Labeling Revision
    • Crestor (rosuvastatin calcium) Tablets, IPR Pharmaceuticals, Inc., Labeling Revision
    • Dalmane (flurazepam hydrochloride) Capsules, Valeant Pharmaceuticals, International, Labeling Revision
    • Lipitor (atorvastatin calcium) Tablets, Pfizer Ireland Pharmaceuticals, Labeling Revision
    • Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
    • Nuvigil (armodafinil) Tablets, Cephalon, Inc., Formulation Revision
    • Theophylline in 5% Dextrose Injection, Hospira, Inc., Labeling Revision
    • Topiramate Tablets, Aurobindo Pharma Ltd., Approval
    • Topiramate Tablets, TEVA Pharmaceuticals USA, Approval
    • Topiramate Tablets, Torrent Pharma Inc., Approval
    • Topiramate Tablets, Cipla Ltd., Approval

CDER Drug Links

Hot Topics

CBER Links

 

 
April 3, 2009
* Class I Medical Device Recall: Tri-State Hospital Supply Corporation - Multiple Trays and Kits Text
 
April 2, 2009
* CDRH Event Problem Codes Text
* Medical Device Safety, Tips & Articles: Danger: "Sandbag" in the MRI Room Text
* Medical Device Safety, Tips & Articles: Exertion Can Disrupt Axillofemoral Bypass Grafts Text
* Medical Device Safety, Tips & Articles: Use Infant Heel Warmers with Care Text
 
April 1, 2009
* Federal Register: Medical Devices; Technical Amendment. Text
* Obstetrics and Gynecology Devices Panel Advisory Meeting, December 13-14, 2007 - Final Minutes Text
* Ophthalmic Devices Panel Advisory Meeting, March 27, 2009 - Final Roster, Final Questions, Slides, Brief Summary Text
* Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, March 31, 2009 - Agenda, Roster, Briefing, Questions, Brief Summary Text
* PMA Final Decisions for February 2009 Text
 
March 30, 2009
* Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products TextPDF
 
News & Events
FDA Public Health Advisory - Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings
FDA Press Release: FDA Warns About Risk of Wearing Medicated Patches During MRIs
National Registry on Safety & Atrial Fibrillation Ablation: An Incubator Thinktank (April 27-28, 2009)
FDA Unique Device Identification Public Workshop: February 12, 2009
Public Health Notifications:
• Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence
• Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status
Class I Medical Device Recalls -
• Welch Allyn AED 10 Automatic External Defibrillator (AED) and MRL JumpStart AED
• Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps
• Covidien Inc., Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube
• Stryker Leibinger USA., Stryker Custom Cranial Implant Kits
• Sun Med Greenline/D MacIntosh No. 3 Laryngoscope Blades

FDA Patient Safety News - A Video News Show for Health Professionals

Medical Device Links

 

This Week Rule Changes:
 21 CFR Parts 814 - 5
 CFR Changes since April 2008

Friday, April 03, 2009
NOTICES
 Agency Information Collection Activities; Proposals, Submissions, and Approvals
 15293–15295 [E9–7471]   [TEXT]  [PDF]
 15295–15296 [E9–7472]   [TEXT]  [PDF]
 

Thursday, April 02, 2009
NOTICES
 Draft Guidance for Industry; Availability:
    Somatic Cell Therapy for Cardiac Disease,
     14992 [E9–7350]   [TEXT]  [PDF]
 

Wednesday. April 01, 2009
RULES
 Revision of Organization and Conforming Changes to Regulations
 14720–14725 [E9–7349]   [TEXT]  [PDF]
 

Tuesday, March 31, 2009
RULES
 Medical Devices:
     Technical Amendment
     14478 [E9–7073]   [TEXT]  [PDF]
 

Monday, March 30, 2009

NOTICES
 Agency Information Collection Activities; Proposals, Submissions, and Approvals,
14135–14137 [E9–7002]   [TEXT]  [PDF]
 

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