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GXPNews.com - FDA News and Announcements  - June 4, 2007 - June 8, 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 &
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Federal Register - Meetings, Notices, &  Rule Changes
CDER Links CBER Links CDRH Links
June 8, 2007

June 7, 2007

  • Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects- Supervisory Responsibilities of Investigators [PDF]
  • Manuals of Policies and Procedures (MaPPs):
    • Alternate Work Schedules for the Office of Training and Communications [PDF]
    • Flexible Workplace Arrangements Program for the Office of Training and Communications [PDF]
    • Guide to the Orientation Program in the Center for Drug Evaluation and Research [PDF]
    • Guide to Assigning Mail Codes in CDER [PDF]
  • CDER Organization Charts [HTML] [PDF] (updated)
  • New and Generic Drug Approvals
    • Capital Soleil 15 Cream, L’Oreal Products, Labeling Revision
    • Divigel (estradiol) Gel, Upsher-Smith Labs, Approval
    • Duricef (cefadroxil monohydrate) Capsules, Warner Chilcott, Labeling Revision
    • Duricef (cefadroxil monohydrate) Oral Suspension, Warner Chilcott, Labeling Revision
    • Duricef (cefadroxil monohydrate) Tablets, Warner Chilcott, Labeling Revision
    • Sufenta (Sufentanil Citrate) Injection, Akorn, Inc., Labeling Revision
    • Topiramate Tablets, Zydus Pharma, Tentative Approval
    • Vantin (cefpodoxime proxetil) Tablets, Pfizer Pharma, Labeling Revision
    • Vantin (cefpodoxime proxetil) Oral Suspension, Pfizer Pharma, Labeling Revision
  • PDUFA IV: Recommendations Transmitted to Congress PDF

June 6, 2007

June 5, 2007

June 4, 2007

  • New and Generic Drug Approvals
    • Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharma, Labeling Revision
    • Avelox (moxifloxacin hydrochloride in NaC1) I.V. Injection, Bayer Pharma, Labeling Revision
    • Fazaclo (clozapine) Orally Disintegrating Tablets, Avanir Pharma, Manufacturing Change or Addition
    • Galantamine Hydrobromide Tablets, Alphapharm, Tentative Approval
    • Gemfibrozil Tablets, Impax Labs, Approval
    • Levaquin (levofloxacin) Tablets, Ortho-McNeil Pharma, Labeling Revision
    • Levaquin (levofloxacin) Injection, Ortho-McNeil Pharma, Labeling Revision
    • Levaquin (levofloxacin) Oral Solution, Ortho-McNeil Pharma, Labeling Revision
    • Minocin (minocycline hydrochloride) Pellet-Filled Capsules, Triax Pharma, Manufacturing Change or Addition
    • Norditropin Cartridges (somatropin [rDNA origin] ) Injection, Novo Nordisk, New or Modified Indication
    • PREVPAC (lansoprazole/amoxicillin/ clarithromycin) Capsule. Tap Pharma, Labeling Revision
    • Risperidone Tablets, Pliva Hrvatska, Tentative Approval
    • Terbinafine Hydrochloride Tablets,  Wockhardt, Tentative Approval
    • Terbinafine Hydrochloride Tablets,  Amneal Pharma, Tentative Approval
    • Zyflo CR (zileuton) Extended Release Tablets, Critical Therapeutics, Approval
  • Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Receipt Date [HTML] or [PDF]
  • Paragraph IV Patent Certifications (updated)

CDER Drug Links
FDA Workshop on Licensure of Apheresis Blood Products - Updated fax number for meeting registration
Posted: 6/8/2007; Meeting Date: 8/15/2007

Vacancy Announcement - Interdisciplinary Scientist, DHT/OCTGT
Posted: 6/8/2007

Approved Biological NDA and ANDA Applications - Update
Posted: 6/6/2007, Updated through: 5/31/2007

Cleared Biological 510(k) Device Applications - Update
Posted: 6/6/2007, Updated through: 5/31/2007

Approved Biological Premarket Approval (PMA) Device Applications - Update
Posted: 6/6/2007, Updated through: 5/31/2007

Licensed Products and Establishments List - Update
Posted: 6/6/2007, Updated through: 5/31/2007

Vacancy Announcement - Regulatory Counsel, RPS/OD
Posted: 6/6/2007

Vacancy Announcement - Regulatory Counsel, RPS/OD
Posted: 6/6/2007

Vacancy Announcement - Paralegal Specialist, RPS/OD
Posted: 6/6/2007

Vacancy Announcement - Supervisory Microbiologist, LMDQC/DBPAP/OVRR
Posted: 6/5/2007

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Receipt Date
Posted: 6/4/2007; Issued: 6/5/200

CBER Links
June 8, 2007
* Class I Medical Device Recall: Abbott Laboratories Inc. ARCHITECT STAT Troponin-I Immunoassay Text
 
June 7, 2007
* Federal Register: Guidance for Industry and Food and Drug Administration Staff; Assayed and Unassayed Quality Control Material; Availability. TextPDF
* Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications (Notice). TextPDF
* Safety Tip: External Defibrillators With "Hands-Free" Capability: Recommendations for Maintaining Their Cables and Connectors Text
 
June 6, 2007
* Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material Text
 
June 4, 2007
* Class I Medical Device Recall: Alcon Refractive Horizons, Inc. LADAR6000 Excimer Laser System Text
* FDA Approves Continuous 7-Day Glucose Monitoring System Text
 

Medical Device Links

Industry Assistance

Health Topics

About CDRH

Device Program Areas

Radiological Health

CFR Rule Changes
This Week - 510 - 522
Friday, June 8, 2007
NOTICES
Committees; establishment, renewal, termination, etc.:
     Public advisory committees and panels—
     Nonvoting industry representatives,
     31841–31842 [E7–11065]   [TEXT]  [PDF]
 
Thursday, June 7, 2007
NOTICES
Agency information collection activities; proposals, submissions, and approvals,
31583–31585 [E7–10911]   [TEXT]  [PDF]

 Human drugs:
     Drug products withdrawn from sale for reasons other than safety or effectiveness—
     CEFOTAN (cefotetan disodium for injection),
     31585–31586 [E7–10959]   [TEXT]  [PDF]
     Patent extension; regulatory review period determinations—
     CHANTIX,
     31588–31589 [E7–10915]   [TEXT]  [PDF]

 Medical devices:
     Premarket approval applications, list; safety and effectiveness summaries; availability,
     31586–31587 [E7–11002]   [TEXT]  [PDF]

 Meetings:
     Science Board; correction,
     31587–31588 [07–2829]   [TEXT]  [PDF]

 Reports and guidance documents; availability, etc.:
     Assayed and Unassayed Quality Control Material,
     31589–31590 [E7–10996]   [TEXT]  [PDF]
     Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis,
     31590 [E7–11001]   [TEXT]  [PDF]
 
Wednesday, June 6, 2007
RULES
 Animal drugs, feeds, and related products:
     Spectinomycin sulfate,
     31177–31178 [E7–10801]   [TEXT]  [PDF]

NOTICES
 Human drugs:
     Patent extension; regulatory review period determinations—
     RAPLON,
     31331–31332 [E7–10853]   [TEXT]  [PDF]

Meetings:
     Endocrinologic and Metabolic Drugs Advisory Committee et al.,
     31332–31333 [E7–10850]   [TEXT]  [PDF]
 
Tuesday, June 5, 2007
RULES
 Animal drugs, feeds, and related products:
     Sponsor name and address changes—
     Watson Laboratories, Inc.
     30970–30971 [E7–10771]   [TEXT]  [PDF]

NOTICES
 Agency information collection activities; proposals, submissions, and approvals,
31074 [E7–10785]   [TEXT]  [PDF]

Committees; establishment, renewal, termination, etc.:
      Public advisory committees—
      Voting members
      31074–31075 [E7–10737]   [TEXT]  [PDF]
      Risk Communication Advisory Committee,
      31075 [E7–10740]   [TEXT]  [PDF]

Human drugs:
      Patent extension; regulatory review period determinations—
      NAMENDA,
      31075–31076 [E7–10730]   [TEXT]  [PDF]

Reports and guidance documents; availability, etc.:
      Advisory Committee Telephone Information Hotline; revision,
     31076–31078 [E7–10738]   [TEXT]  [PDF]
      Refrigerated carrot juice and other refrigerated low-acid juices; safety guidance,
     31078–31079 [E7–10792]   [TEXT]  [PDF]
      Regulatory submissions in electronic format; receipt date,
     31079–31080 [E7–10780]   [TEXT]  [PDF]
 
Monday, June 4, 2007
NONE

 
 

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2007 FDA CFR Handbooks

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GMP Publications.com Code of Federal Regulations Mini-Regulation

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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