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GXPNews.com - FDA News and Announcements - February 16, 2009 - February 20, 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

February 20, 2009

February 19, 2009

  • FDA issues Updated Safety Information about Raptiva (efalizumab). Information

  • Guidance for Industry: Influenza: Developing Drugs for Treatment and/or Prophylaxis [PDF]

  • New and Generic Drug Approvals

    • Heparin Sodium Injection, Baxter Healthcare Corp., Labeling Revision

    • Rapaflo (silodosin) Capsules, Watson Laboratories, Inc., Package Change

    • Revatio (sildenafil citrate) Tablets, Pfizer, Inc., Labeling Revision

    • TobraDex ST (tobramycin and dexamethasone) Ophthalmic Suspension, Alcon, Inc., Approval

    • TOPROL XL (metoprolol succinate) Extended Release Tablets, AstraZeneca LP, Labeling Revision

    • Tracleer (bosentan) Tablets, Actelion Pharmaceuticals, Ltd., Labeling Revision

    • Tramadol Hydrochloride Extended-Release Capsules, Willcox & Savage, P.C., Tentative Approval

    • Uloric (febuxostat) Tablets, Takeda Pharmaceuticals North America, Inc, Approval

    • Zerit (stavudine) Capsules, Bristol-Myers Squibb Co., Labeling Revision

    • Zerit (stavudine) Oral Solution, Bristol-Myers Squibb Co., Labeling Revision

February 18, 2009

February 17, 2009

CDER Drug Links

Hot Topics

CBER Links

 

 
February 19, 2009
* Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on March 18, 2009  TextPDF
* National Registry on Safety & Atrial Fibrillation Ablation: An Incubator Thinktank (April 27-28, 2009) Text
 
February 18, 2009
* Summary Information for: Navistar ThermoCool Catheter and EZ Steer ThermoCool Catheter-Nav PDF
News & Events
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 -
• Stryker Leibinger USA., Stryker Custom Cranial Implant Kits
• Sun Med Greenline/D MacIntosh No. 3 Laryngoscope Blades
• Integra NeuroSciences, Gravity Compensating Accessory
• Advanced Medical Optics, (AMO) Inc., Healon D Ophthalmic Viscosurgical Device (OVD)

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 -
• Stryker Leibinger USA., Stryker Custom Cranial Implant Kits
• Sun Med Greenline/D MacIntosh No. 3 Laryngoscope Blades
• Integra NeuroSciences, Gravity Compensating Accessory
• Advanced Medical Optics, (AMO) Inc., Healon D Ophthalmic Viscosurgical Device (OVD)

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

Medical Device Links

This Week Rule Changes:
 21 CFR Parts - NONE

CFR Changes since April 1st.

Friday, Feb. 20, 2009
NOTICES
 Draft Guidance for Industry on Influenza:
     Developing Drugs for Treatment and/or Prophylaxis; Availability
     7908 [E9–3554]   [TEXT]  [PDF]
 

Thursday, Feb. 19, 2009
NOTICES
 Meetings:
     Circulatory System Devices Panel of the Medical Devices Advisory Committee
     7696–7697 [E9–3488]   [TEXT]  [PDF]
 

Wed. Feb. 18, 2009
NONE

 

Tuesday, Feb. 17, 2009
NOTICES
 International Conference on Harmonisation:
     Draft Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability
     7445–7446 [E9–3168]   [TEXT]  [PDF]

 International Conference on Harmonisation:
     Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts, Uniformity of Dosage Units, etc.,
     7449–7450 [E9–3166]   [TEXT]  [PDF]
     Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts; Dissolution Test, etc.
     7447–7448 [E9–3169]   [TEXT]  [PDF]
     Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts; Sterility Test, etc.
     7446–7447 [E9–3167]   [TEXT]  [PDF]

 Phonetic Orthographic Computer Analysis Software Program for Review of Proprietary Drug and Biologic Names; Availability
 7450 [E9–3170]   [TEXT]  [PDF]
 

Monday, Feb. 16, 2009

NONE
 

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