--------- September 2 - 07 ---------

 

+++ PharmCast.com's Pharmaceutical and Biotech Resources +++

http://www.pharmcast.com/BuyersGuide/PharmResources.htm


Pharmaceutical and Biotech Outsourcing Guide:
    • Agilent Technologies
    • HNC Products
    • Mallinckrodt Pharmaceuticals Outsourcing
    • Patheon
    • Waypharm SAS

Pharmaceutical Training, Software, Studies and Database:
    • Pharmaceutical and Biotech Training Courses
    • Pharmaceutical and Biotech Web Seminars
    • Pharmaceutical Operation Software
    • Pharmaceutical Business Intelligence Studies
 

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

1.  cGMP for Quality Assurance and Quality Control of Pharmaceuticals, Biopharmaceuticals, and Biologics, September 26-28, 2007, Costa Mesa, CA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=095&source=pharmcast
 

2.  Web Seminar: Corrective Action Verifications for 483 Responses to FDA and for the Site Assessment Plan, September 13, 2007. Speaker: Kendall Young, PhD.; President, Blue Sea Consulting.  Organized by BenAstrum, Inc. (Use promotional code PC0907 for 10% discount)

http://benastrum.com/10.html
 

3.  Re-Engineering Physician Relationships Webinar, September 26, 11:00 am EST.  Organized by eyeforpharma.

http://www.eyeforpharma.com/virtual/salesmodel/pharmcast
 

4.  Drug Development India, November 15-16, 2007, Philadelphia, PA.  Organized by Cambridge Healthtech Institute.

http://www.healthtech.com/2007/pci
 

5.  Clinical Trials in CNS, November 26-27, 2007, Central London, United Kingdom.  Organized by SMi Group Ltd.

http://www.smi-online.co.uk/cnstrials9.asp
 

6.  9th Software Design for Medical Devices, November 27-29, 2007, San Diego, CA.  Organized by IQPC.

http://www.iqpc.com/cgi-bin/templates/singlecell.html?topic=221&event=13678
 

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

http://www.eyeforpharma.com/salesusa07
 

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

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

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Aug2007/Home081407OG.htm


1.  Modified vaccinia Ankara expressing p53 in cancer immunotherapy

2.  Human high affinity choline transporter

3.  Non-gelatinous capsule shell composition and a capsule formed from the same

4.  Humanized antibodies that recognize beta amyloid peptide

5.  Combination therapy for osteoporosis

6.  Hybrid system for solubilizing pharmaceutically active substances in polymer matrices

7.  Recombinant P. falciparum merozoite protein-1.sub.42 vaccine

8.  Individualized anti-cancer antibodies

9.  Fenofibrate microparticles

10.  Tyrissamycin antibiotic

11.  Methods for screening compounds that modulate lipid metabolism

12.  Stable benzimidazole formulation

13.  Gene delivery compositions and methods

14.  Botulinum toxin therapy for fibromyalgia

15.  Non-invasive localization of a light-emitting conjugate in a mammal

16.  Methods of preparation and composition of peptide constructs useful for treatment of autoimmune and transplant related host versus graft conditions

17.  Streptococcal C5a peptidase vaccine

18.  Method for immobilization of mediator molecules on metallic and ceramic implant materials

19.  Enkephalinase inhibitor and GABA precursor loading as anti-anxiety compositions

20.  Selecting animals for parentally imprinted traits

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

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

August 31, 2007

1.  Notice: Presidential Interagency Working Group on Import Safety; Public Meeting

2.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

August 30, 2007

1.  Notice: Office of the Commissioner; Statement of Organizations, Functions, and Delegations of Authority

August 29, 2007

1.  Notice: Companion to Guidance for Industry on Pharmacogenomic Data; Availability

2.  Notice: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Orphan Drugs

3.  Notice: In the Matter of Certain Sucralose, Sweeteners Containing Sucralose, and Related Intermediate Compounds Thereof; Notice of Commission Determination Not To Review an Initial Determination Granting the Motion of JK Sucralose To Intervene as Respondent

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

August 28, 2007

1. Final Rule: New Animal Drugs For Use in Animal Feeds; Withdrawal of Approval of a New Animal Drug Application; Bacitracin Zinc

2.  Notice: Foreign-Trade Zone 7--Mayaguez, Puerto Rico, Application for Subzone, MOVA Pharmaceutical Corporation (Pharmaceutical Manufacturing), Manat[iacute], Puerto Rico

3.  Notice: Possession, Use, and Transfer of Select Agents and Toxins

4.  Notice: Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS)

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

August 27, 2007

1.  Notice: Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph, (Due to the size of the Pre-Pub document, the document has been broken into three parts.) (*Large Document, Linked Directly to Federal Register Website)
      a.  Part 1 (PDF)
      b.  Part 2 (PDF)
      c.  Part 3 (PDF)

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

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

August 30, 2007

1.  Human Cell & Tissue and Cellular & Tissue-based Products (HCT/P) Inspections Performed in Fiscal Years 1998 to 2006 - Update (Posted: 8/30/2007)

2.  Influenza Virus Vaccine 2007/2008 Season Lot Release Status - Update (Posted: 8/30/2007)

August 29, 2007

1.  CDER Organization Charts [HTML] [PDF] (updated 8/29/2007)

August 28, 2007

1.  Draft Guidance for Industry: Pharmacogenomic Data Submissions - Companion Guidance (PDF -216 KB) (Posted 8/28/2007)

2.  Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 - Update (Posted: 8/28/2007, Updated as of: 8/28/2007)

3.  Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated 8/28/2007)

August 27, 2007

1.  SOPP 8401.6 - The Responsibilities of the Division of Epidemiology (DE/OBE) in the BLA Review Process (Posted: 8/27/2007)

2.  International Conference on Harmonization (ICH) Public Meeting October 10, 2007, Rockville MD. Meeting information (8/27/2007)

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

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

1.  Novartis Pharmaceuticals (Exelon® (rivastigmine tartrate) Capsules and Oral Solution)

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