--------- September 30 - 07 ---------

 

+++ PharmCast.com's Healthcare MBA Program Highlight+++

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http://mbahc.info/li/


 

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

1.  cGMP for Quality Assurance and Quality Control of Pharmaceuticals, Biopharmaceuticals, and Biologics, October 22-24, 2007, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

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

2.  Web Seminar: Regulatory Aspects of Computer Systems Validation (CSV) and Part 11, October 17, 2007.  Speaker: Johnny Guerra, Ex-FDA President, Guerra Consulting Group Inc.  Organized by BenAstrum, Inc.  Use promotional code PC1007 for 10% discount.

http://benastrum.com/10.html
 

3.  Temperature Controlled Pharmaceutical Distribution, October 8-11, 2007.  Organized by Informa Life Sciences.

http://www.iir-events.com/IIR-Conf/page.aspx?id=7162
 

4.  4th Annual Pharma Sales Force, October 9-10, 2007, Lisbon, Portugal.  Organized by Jacob Fleming Conferences.

http://www.jacobfleming.com/buxus/generate_page.php?page_id=555
 

5.  European Stem Cells Business Summit, October 11-12, 2007, Edinburgh, Scotland.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/ESCBS2007/
 

6.  2nd Data Monitoring Committees, October 15-16, 2007, San Francisco, CA.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=76
 

7.  Evolution Summit, October 17-19, 2007, Monte-Carlo, Monaco.  Organized by Marcus Evans.

http://www.evolution-summit.com
 

8.  2nd Annual Metabolic Syndrome Forum, October 18-19, 2007, Boston, MA.  Organized by Marcus Evans.

http://www.marcusevansbb.com/metabolics
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Sept2007/Home091107OG.htm


1.  Use of insulin for the treatment of cartilaginous disorders

2.  Methods and reagents for the enhancement of virus transduction in the bladder epithelium

3.  Compositions for rapid and non-irritating transdermal delivery of pharmaceutically active agents and methods for formulating such compositions and delivery thereof

4.  Cytomodulating lipophilic peptides for modulating immune system activity and inhibiting inflammation

5.  PEG-LHRH analog conjugates

6.  Composition and methods for inhibiting the progression macular degeneration and promoting healthy vision

7.  Parvovirus vectors and their use

8.  Method for improving oxygen transport by stored red blood cells

9.  Comprehensive pharmacologic therapy for treatment of obesity including cysteine

10.  Enhanced activity alcohol-based antimicrobial compositions

11.  Recombination assembly of large DNA fragments

12.  Diagnostic assay for the human virus causing severe acute respiratory syndrome (SARS)

13.  Therapeutic compositions for intranasal administration which include KETOROLAC

14.  Neurotransmission disorders

15.  Photosensitizer conjugates for pathogen targeting

16.  Methods for treating cancer using cytokine-expressing polynucleotides

17.  Inhalation particles incorporating a combination of two or more active ingredients

18.  Agents for preventing and treating thrombocytopenia

19.  Light stabilized antimicrobial materials

20.  Mitochondrial DNA damage as a predictor of coronary atherosclerotic heart disease

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

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

September 28, 2007

1.  Notice: AHRQ Health Care Innovations Exchange

2.  Notice: Availability of Draft Public Health Service (PHS) Clinical Practice Guideline Update on Treating Tobacco Use and Dependence

September 27, 2007

1.  Notice: Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials; Availability

2.  Notice: Request for Nominations for Voting Members on Public Advisory Committee, Veterinary Medicine Advisory Committee

September 25, 2007

1.  Notice: Draft Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions; Availability

September 24, 2007

1.  Final Rule: Designation of Oripavine as a Basic Class of Controlled Substance

2.  Proposed Rule: Technical Amendment to Listing in Schedule III of Approved Drug Products Containing Tetrahydrocannabinols

3.  Notice (A): Government-Owned Inventions; Availability for Licensing

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

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

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

September 28, 2007

1.  FDA Approves Nasal Influenza Vaccine for Use in Younger Children - 9/19/2007 (Posted: 9/28/2007)

2.  Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays (Posted: 9/28/2007)

3.  Prescription Drug User Fee Act (PDUFA) Billable Products (PDF, updated 9/28/2007)

September 27, 2007

1.  Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (9/27/2007)

September 26, 2007

1.  Influenza Virus Vaccine 2007/2008 Season Lot Release Status - Update (Posted: 9/26/2007)

2.  Workshop on In Vitro Analyses of Cell/Scaffold Products - December 6 & 7, 2007 (9/26/2007)

3.  FDA issues a Public Health Advisory and Healthcare Professional Sheet for Fentora (fentanyl buccal tablets). Drug Information (9/26/2007)

4.  Drug Safety Oversight Board meeting, 8/22/2007; public summary (9/26/2007)

5.  Office of Generic Drugs - News and Announcement Section (updated 9/26/2007)

September 24, 2007

1.  TWC Global LLC, Inc., issues a recall of Axcil and Desirin, both marketed as dietary supplements, because they contain undeclared analogs of sildenafil. MedWatch Safety Information (9/24/2007)

2.  Paragraph IV Patent Certifications (updated 9/24/2007)

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