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GXPNews.com - FDA News and Announcements  - November 19, 2007 - November 23, 2007

The once a week newsletter reporting on what's new within the Food and Drug Administration (FDA)
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Center for Drug Evaluation &
Research (CDER) News
(CBER) Center for Biologics Evaluation & Research Center for Device & Radiological Health (CDRH)

Federal Register - Meetings, Notices, &  Rule Changes

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View CBER Handbooks

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November 21, 2007

November 20, 2007

November 19, 2007

  • FDA updates the FDA Alert and Information for Healthcare Professionals sheet for Avandia
  • Manual of Policies and Procedures (MaPP) Accreditation - Continuing Education [PDF]
  • New and Generic Drug Approvals
    • ABILIFY (aripiprazole) Tablets, Otsuka Pharma, New or Modified Indication
    • ABILIFY (aripiprazole) Oral Solution, Otsuka Pharma, New or Modified Indication
    • ABILIFY (aripiprazole) Orally Disintegrating Tablets, Otsuka Pharma, New or Modified Indication
    • ABILIFY (aripiprazole) Injection Intramuscular, Otsuka Pharma, New or Modified Indication
    • Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) Tablets, Daichi Sankyo, Labeling Revision
    • Children’s Zyrtec (cetirizine HCl) Chewable Tablets, McNeil Consumer, OTC Approval
    • Children’s Zyrtec (cetirizine HCl) Allergy Syrup, McNeil Consumer, OTC Approval
    • EMEND (aprepitant) Capsules, Merck & Co. Inc., Labeling Revision
    • Levaquin (levofloxacin) Tablets, Ortho-McNeil Pharma, Labeling Revision
    • Levaquin (levofloxacin) Injection and Levaquin (levofloxacin in 5% dextrose) Injection, Ortho-McNeil Pharma, Labeling Revision
    • Levaquin (levofloxacin) Oral Solution, Ortho-McNeil Pharma, Labeling Revision
    • Oxcarbazepine Tablets, Taro Pharma, Approval
    • Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca, Approval
    • Zyrtec (cetirizine HCl) Tablets, Pfizer, OTC Labeling

CDER Drug Links

CBER Links

November 20, 2007
* Form: Standards Data Report for 510(k)s - FDA 3654 PDF
 
November 19, 2007
* Federal Register: Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act. TextPDF
* Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Dev TextPDF
* Summary Information for: ARCHITECT CORE-M Reagent Kit, ARCHITECT CORE-M Calibrators, and ARCHITECT CORE-M Controls PDF
* PMA Final Decisions for October 2007 Text
 

Medical Device Links

Industry Assistance

About CDRH

Device Program Areas

CFR Rule Changes
this week - 558

Friday, Nov. 23, 2007

RULES
Animal drugs, feeds, and related products:
    
Ractopamine,
    
65666–65667 [E7–22882]   [TEXT]  [PDF]

NOTICES
Memorandums of understanding:
    
FDA and Duke University; human subjects protection; clinical trials,
    
65745–65749 [07–5793]   [TEXT]  [PDF]

Reports and guidance documents; availability, etc.:
    
Radiofrequency identification feasibility studies; compliance policy guide,

     65750 [E7–22818]   [TEXT]  [PDF]
    
Smallpox (variola) infection: developing drugs for treatment or prevention; industry guidance,
    
65750–65751 [E7–22884]   [TEXT]  [PDF]
    
Stability testing of new veterinary drug substances and medicinal products; industry guidance,
    
65751–65752 [E7–22900]   [TEXT]  [PDF]
    
Veterinary Medicinal Products, International Cooperation on Harmonisation of Technical requirements for Registration—
    
65752–65753 [E7–22901]   [TEXT]  [PDF]
    
65753–65754 [E7–22902]   [TEXT]  [PDF]
    

Thursday, Nov. 22, 2007

NONE

 

Wednesday, Nov. 21, 2007

NONE


 

Tuesday, Nov. 20, 2007

NOTICES
Agency information collection activities; proposals, submissions, and approvals,
65341–65342 [E7–22649]   [TEXT]  [PDF]
 

Monday, Nov. 19, 2007

NOTICES

Agency information collection activities; proposals, submissions, and approvals,
65033–65034 [E7–22480]  
[TEXT]  [PDF]
65034–65036 [E7–22489]  
[TEXT]  [PDF]
65036–65037 [E7–22492]  
[TEXT]  [PDF]
65037–65038 [E7–22495]  
[TEXT]  [PDF]
65038–65039 [E7–22586]  
[TEXT]  [PDF]
65039–65041 [E7–22587]  
[TEXT]  [PDF]
65041–65042 [E7–22588]  
[TEXT]  [PDF]

Food additive petitions:
     ARCH Chemicals, Inc.; withdrawn,
     65042 [E7–22536]  
[TEXT]  [PDF]

Memorandums of understanding:
     Association of American Feed Control Officials; feed ingredients definition, disputes resolution, etc.; responsibilities clarification,
     65042–65046 [07–5748]  
[TEXT]  [PDF]

Reports and guidance documents; availability, etc.:
     Voting Procedures for Advisory Committee Meetings,
     65046–65047 [07–5751]  
[TEXT]  [PDF]