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GXPNews.com - FDA News and Announcements  - November 5, 2007 - November 9, 2007

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Center for Drug Evaluation &
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(CBER) Center for Biologics Evaluation & Research Center for Device & Radiological Health (CDRH)

Federal Register - Meetings, Notices, &  Rule Changes

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November 9, 2007

November 8, 2007

November 7, 2007

November 6, 2007

November 5, 2007

Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications
Posted: 11/9/2007

Biological Product Shortages - Haemophilus b Conjugate Vaccine (PedvaxHIB) information
Posted: 11/9/2007

Background Information Regarding the ISBT Label - Updated
Posted: 11/8/2007

Compliance Program: Chapter 41 - Inspection of Tissue Establishments - Updated
Posted: 11/8/2007

Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Proposed Rule
Posted: 11/8/2007

Background Information Regarding the ISBT Label
Posted: 11/7/2007

FDA Public Workshop: Processing of Orthopedic, Cardiovascular, and Skin Allografts - Transcripts
Posted: 11/7/2007

Influenza Virus Vaccine 2007/2008 Season Lot Release Status - Update
Posted: 11/7/2007

Approved Biological NDA and ANDA Applications - Update
Posted: 11/6/2007, Updated through: 10/31/2007

Cleared Biological 510(k) Device Applications - Update
Posted: 11/6/2007, Updated through: 10/31/2007

Approved Biological Premarket Approval (PMA) Device Applications - Update
Posted: 11/6/2007, Updated through: 10/31/2007

Substantially Equivalent 510(k) Device - PROGESA 4.4h - MAK-System
Posted: 11/6/2007, Clearance Date: 10/26/2007

Vacancy Announcement - Chemist PQLS/DPQ/OVRR
Posted: 11/6/2007

Tissue Reference Group Annual Reports - FY 2007 Update
Posted: 11/5/2007

Workshop: Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development - Agenda
Posted: 11/5/2007


 

November 9, 2007
* Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program.  TextPDF
* Summary Information for: Exponent Self-Expanding Carotid Stent System with Over-the-Wire or Rapid-Exchange Delivery System PDF
* FDA Clears Silver-Coated Breathing Tube for Marketing Text
* Summary Information for: Mitroflow Aortic Pericardial Heart Valve PDF
* Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. TextPDF
* Summary Information for: Tachos DR Atrial Tx Implantable Cardioverter Defibrillator (ICD) System PDF
 
November 6, 2007
* Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. TextPDF
 

Medical Device Links

Industry Assistance

About CDRH

Device Program Areas

CFR Rule Changes
this week - 522 - 558

Friday, November 9, 2007

NOTICES
Agency information collection activities; proposals, submissions, and approvals,
63614–63615 [E7–21971]  
[TEXT]  [PDF]
63615–63616 [E7–21988]  
[TEXT]  [PDF]

Medical devices:
    
Premarket approval applications, list safety and effectiveness summaries availability,
    
63616–63617 [E7–21986]   [TEXT]  
[PDF]
    
Meetings:
    
Medical Devices Advisory Committee,
    
63617–63618 [E7–21979]  
[TEXT]  [PDF]

Reports and guidance documents; availability, etc.:
    
Chronic Obstructive Pulmonary Disease; treatment drugs development,
    
63618 [E7–21985]   [TEXT]  
[PDF]

 

Thursday, November 8, 2007

PROPOSED RULES
Administrative rulings and decisions:
    
Ozone-depleting substances—
    
Epinephrine; removal of essential use designation; meeting,
    
63141–63143 [07–5593]   [TEXT]  [PDF]

Biological products:
    
Human blood and blood components intended for transfusion or further manufacturing use; requirements,
    
63416–63444 [E7–21565]   [TEXT]  [PDF]
 

Wednesday, November 7, 2007

RULES

Animal drugs, feeds, and related products:

     Ivermectin; implantation or injectable dosage form,
     62771 [E7–21839]   [TEXT]  [PDF]

NOTICES

Human drugs:
     New drug applications—
    
Lederle Laboratories et al; approval withdrawn,
     62858–62863 [E7–21886]  
[TEXT]  [PDF]
 

Tuesday, November 6, 2007

RULES

Animal drugs, feeds, and related products:
     Ractopamine,

     62570–62571 [E7–21816]   [TEXT]  [PDF]

NOTICES
Meetings:
    
Medical Devices Advisory Committee,
    
62658 [E7–21779]   [TEXT]  [PDF]
 

Monday, November 5, 2007

NOTICES

Meetings:
    
Adolescent over-the-counter drug products; public workshop,
    
62481–62482 [E7–21713]  
[TEXT]  [PDF]
    
Oncologic Drugs Advisory Committee,
    
62482–62483 [E7–21630]  
[TEXT]  [PDF]