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GXPNews.com - FDA News and Announcements  - August 6, 2007 - August 10, 2007

The once a week newsletter reporting on what's new within the Food and Drug Administration (FDA)
 Distributed by the worlds leader in Federal Regulations,   GMP Publications, Inc.  & FDA.COM - John Cuspilich, Sr. Editor
 

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August 10, 2007

August 9, 2007

August 8, 2007

August 7, 2007

CDER Drug Links

BER Links
August 8, 2007
* Class I Medical Device Recall: Baxter Healthcare Corp. COLLEAGUE and FLO-GARD Volumetric Infusion Pumps (Updated August 8, 2007) Text
* Guidance for Industry and FDA Staff - Procedures for Handling Post-Approval Studies Imposed by PMA Order TextPDF
* Federal Register: Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay. TextPDF
 
August 7, 2007
* Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, July 17, 2007 - Final Questions, Letter to the Record, Slides Text
 
August 6, 2007
* 510(k) Final Decisions - July 2007 Text
* Consumer Information on: Binax Now Malaria Test - K061542 Text
 

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CFR Rule Changes
this week - 866
Friday, August 10, 2007

NOTICES
Agency information collection activities; proposals, submissions, and approvals,
45053 [E7–15612]   [TEXT]  [PDF]
45053–45054 [E7–15614]   [TEXT]  [PDF]
 
Thursday, August 9, 2007
NONE


 
Wednesday, August 8, 2007
RULES
 Medical devices:
     Immunology and microbiology devices—
     In vitro human immunodeficiency virus drug resistance genotype assay; classification,
     44380–44382 [E7–15475]   [TEXT]  [PDF]

NOTICES
 Grant and cooperative agreement awards:
     National Alliance for Hispanic Health,
     44557–44558 [E7–15491]   [TEXT]  [PDF]

 Human drugs:
     Drug products withdrawn from sale for reasons other than safety or effectiveness—
     Methotrexate injection USP preservative free,
     44559–44560 [E7–15490]   [TEXT]  [PDF]
     MIVACRON (Mivacurium Chloride) injection 2 milligrams base/milliliter,
     44558–44559 [E7–15488]   [TEXT]  [PDF]
    
Reports and guidance documents; availability, etc.:
     Hepatitis B; adequate and appropriate donor screening tests; surface antigen assays to test donors of whole blood and blood components,
     44560–44561 [E7–15472]   [TEXT]  [PDF]
     In vitro human immunodeficiency virus drug resistance genotype assay; Class II special controls,
     44561–44562 [E7–15477]   [TEXT]  [PDF]
 
Tuesday, August 7, 2007
PROPOSED RULES
 Administrative rulings and decisions:
     Ozone-depleting substances use; essential-use designations—
     Oral pressurized metered-dose inhalers containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol, etc.; removed,
     44037–44038 [E7–15372]   [TEXT]  [PDF]
    
NOTICES
 Human drugs:
     Drug products withdrawn from sale for reasons other than safety or effectiveness—
     Dexedrine,
     44160–44161 [E7–15236]   [TEXT]  [PDF]
     Prevacid naprapac,
     44159–44160 [E7–15233]   [TEXT]  [PDF]

 Reports and guidance documents; availability, etc.:
     Pediatric studies; medical and clinical pharmacology reviews; summaries,
     44161 [E7–15234]   [TEXT]  [PDF]
 
Monday, August 6, 2007
NOTICES
 Human drugs:
     Drug products withdrawn from sale for reasons other than safety or effectiveness—
     Daranide (dichlorphenamide) tablets, 50 milligrams,
     43645 [E7–15230]   [TEXT]  [PDF]
     PHENERGAN (Promethazine Hydrochloride) suppositories, 12.5 and 25 milligrams,
     43644–43645 [E7–15174]   [TEXT]  [PDF]
     PHOSLO (calcium acetate) 667-milligram tablet,
     43643–43644 [E7–15172]   [TEXT]  [PDF]
 

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2007 FDA CFR Handbooks

GMP Publications.com Code of Federal Regulations Mini-Regulation

ICH Q10 Step 3
US GMP Training Booklet
US GLP Trainer Booklet
US GCP Trainer Booklet
Combination Product handbook
Standard-GMPs Parts 11, 210, 211, 820 & ICH Q7A
Med. Device - 11, 50, 54, 56, 807, 812, 814, 820, 510k/PMA
Clinical GCP - Parts 11, 50, 54, 56, 312, 314 & ICH E2A & E6
Multi-US GMPs 11, 58, 210/211, 600, 601, 610  & 820
Parts 210/211 - Drug GMPs
>210/211 with Part 11
>210/211 with Part 820
>210/211 with Parts 820 & 11
>210/211 w/ Keyword Index

Part 820 Quality Systems Regs

Part  58 - GLP Good Lab. Practice

Part 11 - Electronic Records w/ Scope and Applications

GLP 2 11 & 58 - Part 11 & 58

PDMA 11, 203 & 205 - Prescription Drug Marketing

11 & 210/211 w/ Keyword Index

11 & 820 Electronic Record and Quality Systems

Biological GMPs 600, 601, 610

more...

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