--------- January 27 - 08 ---------

 

+++ USP (United States Pharmacopeia) Training Course Highlight+++
 

1.  Advanced Dissolution (Classroom/Online)

http://www.usp.org/goto/phcadv
 

2.  Ensuring Dosage Unit Uniformity - General Chapter <905> (Classroom/Online)

http://www.usp.org/goto/phcdos
 

3.  WEBINAR eSymposium (Online)

http://www.usp.org/goto/phcesym
 

4.  cGMP: A Quality Systems Approach for APIs (Classroom/Online)

http://www.usp.org/goto/phcgmp
 

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

1.  Overview of FDA Regulatory Compliance For Medical Devices, March 3-4, 2008, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

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

2,  Navigating Chapter <467> Residual Solvents (Classroom/Online) Organized by USP (United States Pharmacopeia).

http://www.usp.org/goto/phcnav
 

3,  Web Seminar: Pharmaceutical Water Issues - PREVENT, AUDIT and CONTROL, February 20, 2008.  Speaker: Frank S. Kohn, PhD.  Organized by BenAstrum, Inc. (Use promotional code PC0208 for 10% discount)

http://www.benastrum.com/index.php?option=com_content&task=view&id=39&Itemid=69
 

4.  2nd Search Engine Marketing for Pharmaceuticals, February 25-26, 2008, Philadelphia, PA.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=97
 

5.  3rd Data Monitoring Committees Conference, February 25-26, 2008, Philadelphia, PA.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=100
 

6.  5th Lean Six Sigma For Pharmaceutical, Biotech and Medical Device Excellence, February 25-27, 2008, Philadelphia, PA.  Organized by IQPC.

http://www.iqpc.com/us/LSSP
 

7.  2nd Annual Conference on Recombinant Therapeutics, February 25-27, 2008, Berlin, Germany.  Organized by IQPC.

http://www.iqpc.com/de/recombinant/pharmcast
 

8.  The 7th Pharmaceutical Powder X-ray Diffraction Symposium, February 25-28, 2008, Orlando, FL.  Organized by the International Centre for Diffraction Data.

http://www.icdd.com/ppxrd
 

9.  SecurePharma 2008, February 26-27, 2008, Philadelphia, PA.  Organized by Worldwide Business Research.

http://www.SecurePharma2008.com
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2008/Jan2008/Home010808OG.htm
 

1.  Influenza vaccine composition

2.  Mutant glycoproteins

3.  Mixture for transdermal delivery of low and high molecular weight compounds

4.  Basal cell carcinoma tumor suppressor protein

5.  Use of ramoplanin to treat diseases associated with the use of antibiotics

6.  Process for the in vitro culture of different stages of tissular parasites

7.  Temperature and pH sensitive copolymers

8.  Glucose dependent release of insulin from glucose sensing insulin derivatives

9.  Method of determining adenovirus particle concentration

10.  Method for preserving organs for transplant

11.  Small peptides having anti-angiogenic and endothelial cell inhibition activity

12.  Site-specific preparation of polyethylene glycol-GRF conjugates

13.  Method of treating peripheral neuropathy

14.  Compositions and methods for non-targeted activation of endogenous genes

15.  Immunization of fish with plant-expressed recombinant proteins

16.  Conformable tissue repair implant capable of injection delivery

17.  CD38 as a prognostic indicator in B cell chronic lymphocytic leukemia

18.  Immortalized vascular adventital cell line

19.  Liposome drug delivery of polycyclic, aromatic, antioxidant or anti-inflammatory compounds

20.  Methods and means for influencing intracellular communication and intracellular organelle transport

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

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

January 25, 2008

1.  Notice: Determination That SEROQUEL (Quetiapine Fumarate) Tablets, 150 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

2.  Notice: Request for Nominations for Voting Consumer Representative Members on Public Advisory Committees

3.  Notice: Prospective Grant of Exclusive License: Human Monoclonal Antibodies, Their Fragments and Derivatives as Biotherapeutics for the Treatment of HIV Infections

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

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

6. Notice (C): Government-Owned Inventions; Availability for Licensing

7. Notice (D): Government-Owned Inventions; Availability for Licensing

8. Notice (E): Government-Owned Inventions; Availability for Licensing

January 24, 2008

1.  Notice: WTO Dispute Settlement Proceedings Regarding Measures of the European Communities Affecting the Approval and Marketing of Biotech Products

2.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys

January 23, 2008

1. Notice of Availability: Secretarial Recognition of Certain Healthcare Information Technology Standards Panel (HITSP) Interoperability Specifications as Interoperability Standards for Health Information Technology

January 22, 2008

1.  Notice: Regulatory Site Visit Training Program

2.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice

3.  Notice: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Institutional Review Boards

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

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

January 25, 2008

1.  Clarification of Recent FDA Initiatives Affecting OTC Drugs (1/25/2008)

2.  Massachusetts Biotechnology Council's Annual Luncheon - 1/22/2008 (Slide Presentation, Posted 1/25/2008)
    a.  Resolutions and Revolutions – Some Perspectives (PDF 286 KB) - Jesse Goodman, MD, MPH

January 24, 2008

1.  Bayer and FDA inform healthcare professionals of the market withdrawal of the current liquid formulation of Leukine (sargramostim).  MedWatch Information (1/24/2008)

January 23, 2008

1.  Guidance for Industry: Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2008 (PDF, Updated 1/23/2008)

2.  Drug Shortages (1/23/2008)
    a.  Current Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial containing EDTA
    b.  Resolved Drug Shortage: Amytal (amobarbital sodium) injection Company Information

January 22, 2008

1.  FDA approves additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label (1/22/2008)

2.  Regulatory Site Visit Training Program (Posted: 1/22/2008)

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

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

1.  Tomita Pharmaceutical Co., Ltd (Site Inspection)

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