--------- July 8 - 07 ---------

 

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

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http://mbahc.info/li/


 

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

1.  Overview of FDA Regulatory Compliance for Medical Devices, August 6-7, 2007, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=020&source=pharmcast
 

2.  Web Seminar: The Essentials of Effectively Managing QA/QC Departments, July 25, 2007. Speaker: Mr. Edwin Mercado, President, MIPA Inc.  Organized by BenAstrum, Inc.  Use promotional code PC0707 for 10% discount.

http://benastrum.com/10.html
 

3.  2nd Annual Total Market Forecasting in Pharma 2007, September 25-26, 2007, Philadelphia, PA.  Organized by ViB Events.

http://www.market-forecasting.com/usa/index.html
 

4.  Electronic Laboratory Notebooks & Data Management Technology 2007, September 26-28, 2007, Brussels, Belgium.  Organized by IQPC.

http://www.iqpc.com/be/eln/pharmcast
 

5.  3rd Annual Project and Portfolio Management, September 27-28, 2007, Amsterdam, the Netherlands.  Organized by Jacob Fleming Conferences.

http://www.jacobfleming.com/buxus/generate_page.php?page_id=416
 

6.  2nd Annual Leadership Summit on Revenue Cycle Innovations, September 27-28, 2007, Washington, DC.  Organized by World Congress. ($400.00 discount to PharmCast.com's visitors; use code: JZE558)

http://www.worldcongress.com/revenuecycle
 

7.  Pharma & Biotech Competitive Intelligence & Business Analysis Conference, October 1-2, 2007, New Brunswick, NJ.  Organized by Apaporis.

http://www.pharmabiotechci.com/
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/June2007/Home061907OG.htm


1.  Throat lozenge for the treatment of Streptococcus Group A

2.  Adenovirus vectors, packaging cell lines, compositions, and methods for preparation and use

3.  Methods for treating HIV infected subjects

4.  IL-16 antagonists

5.  Chimeric IgE polypeptides and host cells

6.  Compositions and methods for treating hyperimmune response in the eye

7.  PPAR Ligands that do not cause fluid retention, edema or congestive heart failure

8.  Antibodies against tumor surface antigens

9.  Fermentation process using specific oxygen uptake rates as a process control

10.  Method for treatment of neurodegenerative diseases and effects of aging

11.  Diagnostic agents for pancreatic exocrine function

12.  Infectious cDNA clone of North American porcine reproductive and respiratory syndrome (PRRS) virus and uses thereof

13.  Compositions and methods for promoting myocardial and peripheral angiogenesis

14.  Cell lines with latent immunodeficiency virus and methods of use thereof

15.  Method and device for detecting and isolating pharmacological compounds being contained in substance mixtures

16.  Methods of treating rosacea

17.  Termini cysteine-added variants of granulocyte colony stimulating factor

18.  Methods for reducing cholesterol using Bacillus coagulans spores, systems and compositions

19.  Method of manufacturing a stellate cell death factor

20.  Diagnostic agents for the prenatal diagnosis of preterm delivery, fetal infection, and fetal damage, and diagnostic kit containing the same

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

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

July 6, 2007

1.  Notice: National Center for Research Resources 2009 Strategic Plan

2.  Notice: Cooperative Agreement to Support the Joint Institute for Food Safety and Applied Nutrition

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

July 5, 2007

1.  Notice: Prospective Grant of Exclusive License: Method for the Diagnosis and Treatment of Vascular Disease

2.  Notice: Prospective Grant of Exclusive License: The Development of Human Therapeutics for the Treatment of Cancer

July 3, 2007

1.  Notice: Clinical Studies of Safety and Effectiveness of Orphan Products; Availability of Grants; Request for Applications: RFA-FD08-001; Research Project Grants (R01); Catalog of Federal Domestic Assistance Number: 93.103

2.  Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin; Availability

3.  Notice: Draft Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document; Availability

4.  Notice: Medical Devices; General Hospital and Personal Use Devices; Classification of the Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies; Availability

July 2, 2007

1.  Final Rule: Changes in the Regulation of Iodine Crystals and Chemical Mixtures Containing Over 2.2 Percent Iodine

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

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

July 6, 2007

1.  Guidance for Industry: ANDAs: Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information [PDF] (7/6/2007)

2.  Public Meeting on Essential Uses of Ozone Depleting Substances August 2, 2007, Rockville, MD (7/6/2007)

3.  Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (Posted 7/6/2007)

July 5, 2007

1.  Questions and Answers Concerning the Current Good Tissue Practice (CGTP) Final Rule - Updated (Posted: 7/5/2007)

2.  Questions and Answers Concerning the Donor Eligibility Final Rule and Guidance - Updated (Posted: 7/5/2007)

3.  FDA approves the first generic versions of prescription Lamisil (terbinafine hydrochloride) tablets, used to treat nail fungus infection (onychomycosis). FDA News (7/5/2007)

4.  Pediatrics: Pediatric Research Equity Act (PREA) Labeling Changes (7/5/2007)

July 3, 2007

1.  Drug Safety Oversight Board Meetings Public Summaries, April 19 (7/3/2007)

2.  Paragraph IV Patent Certifications (updated 7/3/2007)

July 2, 2007

1.  FDA issues a safety alert for omalizumab (marketed as Xolair). Omalizumab Information (7/2/2007)

2.  Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document [HTML] or [PDF] (updated 7/2/2007)

3.  Guidance for Industry: Comprehensive List of Guidance Documents (PDF, updated 7/2/2007)

4.  Guidance for Industry: New/Revised/Withdrawn List for 2007 (PDF, updated 7/2/2007)

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