--------- February 3 - 08 ---------

 

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

1.  Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products, March 17-18, 2008, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=005&source=pharmcast
 

2.  Laboratory Practicum for Chapter <467> Residual Solvents (2 day) (Classroom)  Organized by USP (United States Pharmacopeia).

http://www.usp.org/goto/phcnav
 

3.  Web Seminar: Analytical Method Validation, February 21, 2008.  Speaker: Johnny Guerra, ex-FDA.  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.  Early Commercial Input and Pharma / Biotech Product Lifecycle Management Strategies, February 28-29, 2008, San Diego, CA.  Organized by Arrowhead Conferences.

http://www.arrowheadpublishers.com/conferences/product-lifecycle-management/index.php
 

5.  2nd Annual Clinical Trials Excellence, March 3-4, 2008, Singapore.  Organized by Marcus Evans.

http://www.marcusevans.com/html/eventdetail.asp?eventID=13308&SectorID=31&divisionID=
 

6.  Post-Approval Drug Surveillance, March 10-11, 2008, Philadelphia, PA.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=101
 

7.  Electronic Laboratory Notebooks: Optimising Data Management, Integration & Global Roll-Out, March 10 - 12, 2008, Frankfurt, Germany.  Organized by IQPC.

http://www.iqpc.com/de/eln
 

8.  6th Annual Pharma Branding Conference, March 13-14, 2008, Barcelona, Spain.  Organized by Jacob Fleming Conferences.

http://www.jacobfleming.com/conferences/life-science/6th-annual-pharma-branding-2?preview_type=from_menu
 

9.  2008 BioPharma Outsourcing: Partnerships with CROs and Other Service Providers, March 25-26, 2008, Boston, MA.  Organized by iiBIG.

http://www.iibig.com/P0803

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

http://www.pharmcast.com/PatentToSubWeb/Yr2008/Jan2008/Home011508OG.htm
 

1.  Molecular vaccine linking intercellular spreading protein to an antigen

2.  Method for distinguishing follicular thyroid adenoma (FTA) from follicular thyroid carcinoma (FTC)

3.  Polynucleotides encoding a multiple epitope fusion antigen for use in an HCV antigen/antibody combination assay

4.  Method for treating wounds to promote healing

5.  TAG-72 specific C.sub.H2 domain deleted antibodies

6.  Methods and compositions for using alveolar macrophage phospholipase A2

7.  Sustained release formulation

8.  Nucleic acid underexpressed in melanoma

9.  Method for isolation of silymarin from Sylibum marianum seeds

10.  Therapeutic compositions that alter the immune response

11.  Minimization of drug oxidation in drug irradiated excipients formulations

12.  Methods of use for antibodies against parathyroid hormone

13.  Increased and sustained in vivo gene expression using a nucleic acid, histone and amphipathic compound composition

14.  Herbal formulation for treatment of depression and other related disorders and method of preparing the same

15.  Biological scaffolding material

16.  Rapid assays for neurotransmitter transporters

17.  Antibodies against cancer

18.  Method for generating hypermutable organisms

19.  Compositions and methods for eliciting immune or anti-infective responses

20.  Materials and methods relating to polyions and substance delivery

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

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

February 1, 2008

1.  Final Rule: Skin Protectant Drug Products for Over-the-Counter Human Use; Reduced Labeling; Technical Amendment

2.  Notice: Request for Notification from Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative on the Blood Products Advisory Committee and Request for Nominations for a Nonvoting Industry Representative on the Blood Products Advisory Committee

January 31, 2008

1.  Proposed Rule: Schedules of Controlled Substances: Placement of Indiplon Into Schedule IV

January 30, 2008

1.  Notice: Guidance for Industry and Food and Drug Administration Staff; Clinical Laboratory Improvement Amendments of 1988: Recommendations for Clinical Laboratory Improvement Amendments of 1988: Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Availability

January 29, 2008

1.  Notice: Approval for Manufacturing Authority Merck Sharpe & Dohme Quimica de Puerto Rico Inc. (Pharmaceutical Products) Caguas, PR

January 28, 2008

1.  Notice: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey of Food Safety and Nutrition Information Provided to Pregnant Women by Health Care Providers and the Special Supplemental Nutrition Program for Women, Infants, and Children Educators

2.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act

3.  Notice: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food and Drug Administration Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products

4.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements

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

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

February 1, 2008

1.  Guidance Documents (Updated 2/1/2008)
     a.  Comprehensive List of Guidance Documents (PDF)
     b.  New/Revised/Withdrawn List for 2008 (PDF)
     c.  New/Revised/Withdrawn List for 2007 (PDF)

January 31, 2008

1.  FDA issues an FDA Alert and Information for Healthcare Professional sheet for suicidality and antiepileptic drugs (Posted 1/31/2008)

2.  Washington Vaccine Forum 2008 - 1/30/2008 (Posted 1/31/2008)
     a.  Vaccine Safety and Risk Management Update (PDF 67 KB) - Florence Houn, MD, MPH

January 30, 2008

1.  2nd Annual FDA/DIA Statistics Forum, Marriott Bethesda, Bethesda, MD, April 13-16, 2008 Meeting Information (1/30/2008)

2.  Paragraph IV Patent Certifications (updated 1/30/2008)

January 29, 2008

1.  Recall of Recall of White-Faced Hornet Venom Protein - Hollister Stier Laboratories LLC - 1/7/2008 (Posted 1/29/2008)

2.  Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis - Update (Posted: 1/29/2008, Updated as of: 1/28/2008)

3.  Drug Master Files (updated 1/29/2008)

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