--------- November 4 - 07 ---------

 

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+++ PharmCast.com's Conference Highlight +++
 

1.  How to Prepare for a Systems-Based Inspection - Understanding the FDA’s Risk-based Inspections Approach and Ensuring Compliance, December 17-18, 2007, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=094&source=pharmcast
 

2.  Web Seminar: Preparing for a Successful FDA Inspection November 20, 2007.  Speaker: Kerry Potter, Founder, Summit Consulting Inc.  Organized by BenAstrum, Inc. (Use promotional code PC1107 for 10% discount)

http://benastrum.com/10.html
 

3.  CHI's In Vitro Molecular Imaging (part of Imaging Week), November 29-30, 2007, San Diego, CA.  Organized by Cambridge Healthtech Institute.

http://www.Imaging-Week.com
 

4.  Sales Force Effectiveness USA 2007, November, 2007, Venue TBC.  Organized by eyeforpharma.

http://www.eyeforpharma.com/salesusa07
 

5.  Pharmacovigilance Summit 2007, December 3-4, 2007, Philadelphia, PA.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=88
 

6.  World Drug Discovery & Development Summit 2007, December 4-5, 2007, Cologne, Germany. Organised by World Trade Group.

http://www.wddsummit.com
 

7.  Pharma Demand Planning & Supply Chain Excellence 2007, December 4-5, 2007, London, UK.  Organized by eyeforpharma.

http://www.eyeforpharma.com/supplychain07/pharmcast
 

8.  FDA/CMS Summit, December 6-7, 2007, Washington DC.  Organized by Windhover Information, Inc.

http://www.windhover.com


 

+++ PharmCast.com's Last Week Pharmaceutical Patents +++
 

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Oct2007/Home101607OG.htm


1.  Mixed-cell gene therapy

2.  Methods and compositions for directing cells to target organs

3.  Hyperthermia agent for malignant tumor comprising cytokine and magnetic fine particles

4.  Multidirectional morphology and mechanics of osteonic lamellae

5.  Protein molecule useful for inhibition of anthrax toxin

6.  Human monoclonal antibodies against interleukin 8 (IL-8)

7.  Methods for identifying an analog that promotes nerve regeneration

8.  Compositions, methods and kits for diagnosis and treatment of Chlamydia pneumoniae infections of the skin and those associated with cutaneous T-cell lymphoma

9.  Powdery preparation for transmucosal administration containing a polymeric form of drug and exhibiting improved storage stability

10.  Hepatocytes for therapy and drug screening made from embryonic stem cells

11.  Method for treating bacterial infections in horses or pigs with tilmicosin

12.  Osteopontin-related compositions and methods

13.  Monoclonal antibody hPAM4

14.  Proaerolysin containing protease activation sequences and methods of use for treatment of prostate cancer

15.  Rapidly disintegrable tablets

16.  RNA interference pathway genes as tools for targeted genetic interference

17.  Method for stimulating wound healing

18.  Nanoparticles for protein drug delivery

19.  Compositions and methods for the treatment of immune related diseases

20.  Genipin-crosslinked gelatin microspheres as drug carrier

+++ PharmCast.com's Last Week Federal Register +++
 

http://www.pharmcast.com/FederalRegistrar/FRHome.htm
 

November 1, 2007

1.  Notice: Notice of Availability of Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine

October 31, 2007

1.  Notice: Guidance for Industry on the Role of Human Immunodeficiency Virus Resistance Testing in Antiretroviral Drug Development; Availability

2.  Notice: Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers; Availability

3.  Notice: Office of Biotechnology Activities; Recombinant DNA Research: Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)

4.  Notice: Government-Owned Inventions; Availability for Licensing

October 30, 2007

1.  Notice: Draft Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability

2.  Notice: Biomin GmbH; Filing of Food Additive Petition

October 29, 2007

1.  Notice: Guidance for Industry: Considerations for Plasmid Deoxyribonucleic Acid Vaccines for Infectious Disease Indications; Availability

2.  Notice: Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility; Availability

+++ PharmCast.com's Last Week Recent FDA Links +++

http://www.pharmcast.com/FDALinks/FDALinksLatest.htm
 

November 2, 2007

1.  Human Gene Therapies, Novel Product Development: Q & A with Celia Witten, Ph,D., M.D. - 10/15/2007 (Posted 11//2/2007)

2.  Consumer Update: Wider Age Range for Bacterial Meningitis Vaccine - 10/29/2007 (Posted 11//2/2007)

3.  Consumer Update: Should Your Child Be in a Clinical Trial? - 10/15/2007 (Posted 11//2/2007)

November 1, 2007

1.  Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers (PDF - 53 KB) (Posted 11/1/2007)

October 31, 2007

1.  Office of Generic Drugs:
    a.  Requesting a Pre-Assigned Electronic Common Technical Document (eCTD) Number from Office of Generic Drugs (10/31/2007)

2.  FDA approves Tasigna (nilotinib) for the treatment of Philadelphia chromosome positive chronic myeloid leukemia. (10/31/2007)

October 30, 2007

1.  Postmarketing Study Commitments Search (updated 10/30/2007)

2.  Guidance for Industry: Role of HIV Resistance Testing in Antiretroviral Drug Development [PDF] (10/30/2007)

October 29, 2007

1.  CellCept (mycophenolate mofetil) - Changes to prescribing information due to increased risk of first trimester pregnancy loss and increased risk of congenital malformations (10/29/2007)

2.  Guidance for Industry: Acute Bacterial Sinusitis: Developing Drugs for Treatment [PDF] (10/29/2007)

3.  ISBT Label Checklist for Licensed Establishments (Posted: 10/29/2007)

4.  Draft Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions (Posted: 10/29/2007)

5.  Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (Posted: 10/29/2007)

+++ PharmCast.com's Recent FDA Warning Letters +++

http://www.pharmcast.com/WarningLetters/LatestWL.htm
 

1.  Northeast General Pharmaceutical Factory (Site Inspection)

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