--------- July 15 - 07 ---------

 

+++ PharmCast.com's Company Highlight+++
 

Mallinckrodt Pharmaceuticals Outsourcing, a business unit of Tyco Healthcare, is a contract manufacturer specializing in high-quality solid dose and oral liquid finished products.  We draw on the knowledge and experience of over 3,000 professionals, whose skills span from product development and manufacturing solutions, all the way through to product launch.  Our facility is located in the United States and is FDA and DEA I-V compliant.

http://www.pharmcast.com/BuyersGuide/Mallinckrodt/MallinckrodtComInfo.htm


 

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

1.  Selecting and Managing CRO’s, August 15-16, 2007, Costa Mesa, CA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=086&source=pharmcast
 

2.  Web Seminar: An Auditor’s Guidance in Preparing for FDA Audits, July 26, 2007.  Speaker: Ms. Bernice Russell-Bond President, BRUSSELL Consulting Inc.  Organized by BenAstrum, Inc.  Use promotional code PC0707 for 10% discount.

http://benastrum.com/10.html
 

3.  Discovery Chemistry Congress, October 3-4, 2007, South San Francisco, CA.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/DiscChemCongress07/
 

4.  Microwave-Assisted Organic Synthesis (MAOS), October 3-4, 2007, San Francisco, CA.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/MAOS2007/
 

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

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

6.  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
 

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

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

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/June2007/Home062607OG.htm


1.  Medicaments for initiating ovulation

2.  Brain-associated inhibitor of tissue-type plasminogen activator

3.  Method of treating glutathione deficient mammals

4.  Interferon alpha hybrids

5.  Formulation of adenovirus for gene therapy

6.  Vaccine against Gram-negative bacterial infections

7.  Paramagnetic particles that provide improved relaxivity

8.  Serotype 5 adenoviral vectors with chimeric fibers for gene delivery in skeletal muscle cells or myoblasts

9.  Multiple agent therapy for sexual dysfunction

10.  Transgenic animals with increased slow-twitch muscle fibers and methods of using such animals

11.  Method for determining cell cycle position

12.  Methods and compositions for culturing spirochete and treating spirochetal diseases

13.  Use of microparticles having a protein and an antibody adsorbed thereon for preparing a pharmaceutical composition for intranasal administration

14.  Use of treosulfan and derivatives thereof for treating multiple sclerosis

15.  Protein and process for producing the same

16.  Antibodies and methods for generating genetically altered antibodies with high affinity

17.  Method for mutation detection in HIV-1 using pol sequencing

18.  Methods for the treatment of hepatic disorders

19.  Bacterial delivery system

20.  Biological bioadhesive compositions and methods of preparation and use

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

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

July 13, 2007

1.  Notice: Global Harmonization Task Force, Study Groups 1 and 5; New Proposed and Final Documents; Availability

2.  Notice: International Conference on Harmonisation; Draft Guidance on Q10 Pharmaceutical Quality System; Availability

3.  Notice: Availability of Funding Opportunity Announcement

July 12, 2007

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

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

July 11, 2007

1.  Notice: Determination That ARISTOCORT FORTE Injectable Suspension (Triamcinolone Diacetate), 40 Milligrams per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

July 10, 2007

1. Interim Final Rule: Import and Production Quotas for Certain List I Chemicals

July 9, 2007

1.  Notice: Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information; Availability

2.  Notice: Draft Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims; Availability

3.  Notice: Draft Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New Drug Applications for Products Intended to Repair or Replace Knee Cartilage; Availability

4.  Notice: Use of Ozone-Depleting Substances; Removal of Essential-Use Designations; Public Meeting

5.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request, Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions

6.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Presubmission Conferences, New Animal Drug Applications and Supporting Regulations and Guidance 152, and Form FDA 356V

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

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

July 13, 2007

1.  Fast Track Designation Request Performance - Updated (Posted: 7/13/2007)

2.  Workshop: Licensure of Apheresis Blood Products - Agenda (Posted: 7/13/2007)

July 12, 2007

1.  Guidance for Industry: Q10 Pharmaceutical Quality System [PDF] (Updated 7/12/2007)

2.  Questions and Answers Concerning the June 19, 2007 Final Rule: Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing; and Related Labeling (Posted: 7/12/2007)

3.  Drug Approval Reports (Updated 7/12/2007)
    a.  Accelerated and Restricted Approvals Under Subpart H (drugs) and Subpart E (biologics)
    b.  Efficacy Supplement Approvals
    c.  NDA and BLA Approvals
    d.  NME Drug and New Biologic Approvals
    e.  Priority NDA and BLA ApprovalsPriority NDA and BLA Approvals

July 11, 2007

1.  Approved Biological NDA and ANDA Applications - Update (Posted: 7/10/2007, Updated through: 6/30/2007)

2.  Cleared Biological 510(k) Device Applications - Update (Posted: 7/10/2007, Updated through: 6/30/2007)

3.  Approved Biological Premarket Approval (PMA) Device Applications - Update (Posted: 7/10/2007, Updated through: 6/30/2007)

July 10, 2007

1.  National Drug Code Directory Search (updated 7/10/2007)

2.  National Drug Code Directory Download (updated 7/10/2007)

July 9, 2007

1.  Inactive Ingredient Database (updated 7/9/2007)

2.  CDER Organization Charts [HTML] [PDF] (updated 7/9/2007)

3.  CDER Key Officials (updated 7/9/2007)
 

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

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

1.  Sitek Research Laboratories (BMIS Inspection)

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