--------- January 6 - 08 ---------

 

+++ CfPIE's Pharmaceutical/Biotech Training Course Highlight+++

1.  Root Cause Analysis for CAPA, Jan. 28 - 30, 2008, Malvern, PA.

http://www.cfpie.com/showitem.aspx?productid=069&source=pharmcast
 

2.  Cleanroom Microbiology for the Non-Microbiologist, Feb. 4 & 5, 2008, Costa Mesa, CA.

http://www.cfpie.com/showitem.aspx?productid=016&source=pharmcast
 

3.  How to Implement Risk Management Principles and Activities Within a Quality Management System, Feb. 5 & 6, 2008, Malvern, PA.

http://www.cfpie.com/showitem.aspx?productid=041&source=pharmcast
 

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

1.  Writing Effective Standard Operating Procedures and Other Process Documents, February 4-5, 2008, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=083&source=pharmcast
 

2.  cGMP: A Quality Systems Approach for APIs (Classroom/Online).  Organized by USP (United States Pharmacopeia).

http://www.usp.org/goto/phcgmp
 

3.  Web Seminar: Good Documentation Practices Preface for the Pharmaceutical Laboratory, January 29, 2008.  Speaker: Kerry P. Potter.  Organized by BenAstrum, Inc. (Use promotional code PC0108 for 10% discount)

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

4.  Pharmaceutical Patent Litigation Strategies 2008, March 31 - April 1, 2008, London, UK.  Organized by IQPC.

http://www.iqpc.com/uk/patlit/diary
 

5.  2nd Annual Pharmaceutical Sales & Marketing Executive Congress, March 31 – April 1, 2008, Bethesda, MD.  Organized by iiBIG.

http://www.iibig.com/P0802
 

6.  Chiral Processes: Master Separation: Crystallisation - Purification - Scale-Up - Patenting, March 31 - April 2, 2008, Berlin, Germany.  Organized by IQPC.

http://www.iqpc.com/de/chiral
 

7.  Laboratory Informatics, March 31 - April 3, 2008, San Francisco, CA.  Organized by IQPC.

http://www.iqpc.com/us/lab
 

8.  5th Annual World Health Care Congress (WHCC), April 21-23, 2008, Washington, DC.  Organized by World Congress. ($300.00 discount to PharmCast.com's visitors; use code: MPR729)

http://www.worldcongress.com/events/HR08000/index.cfm?confCode=HR08000
 

9.  ePharma Summit 2008, January 28-30, 2008, Philadelphia, PA.  Organized by the Institute for International Research.

http://www.epharmasummit.com
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Dec2007/Home121807OG.htm
 

1.  Reducing myelin-mediated inhibition of axon regeneration

2.  Fish gelatin hard capsule and its preparation method

3.  Amelioration of Dupuytren's disease

4.  Transgenic mice knockouts of BACE-1

5.  Nucleic acid molecules encoding bacterial autoinducer inactivation protein as targets for engineering disease resistance

6.  Adsorbents for dilated cardiomyopathy

7.  Modified cytokines for use in cancer therapy

8.  PRO12970 antibodies

9.  Stabilized pharmaceutical preparation of gamma-aminobutyric acid derivatives and process for preparing the same

10.  Extract of Acanthopanax koreanum for the treatment or prevention of hepatitis or the liver protective drug

11.  Microparticles

12.  Growth hormone-regulatable liver genes and proteins, and uses thereof

13.  Topical anti-cancer compositions and methods of use thereof

14.  Biodegradable absorbents and methods of preparation

15.  gM-negative EHV-mutants

16.  Methods and compositions for detecting and treating retinal diseases

17.  Pharmaceutical compositions for treating and saving and the method for the preparation thereof

18.  Conditioned media to inhibit growth of tumor cells

19.  Injectable pharmaceutical composition for systematic administration of pharmacologically active ingredients

20.  Method of identifying transmembrane protein-interacting compounds

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

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

January 4, 2008

1.  Notice: Draft Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval; Availability; Reopening of Comment Period

2.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug

3.  Notice: Request for Comments on the Science and Technology Report; Establishment of Docket; Request for Comments

January 3, 2008

1.  Interim Final Rule: Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products

2.  Proposed Rule: Schedule for Rating Disabilities; Evaluation of Residuals of Traumatic Brain Injury (TBI)

January 2, 2008

1.  Notice: Draft Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability

2.  Notice: Guidance for Industry and Food and Drug Administration; Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements; Availability

3.  Notice: Medicine Shoppe--Jonesborough; Revocation of Registration (*Large Document, Linked Directly to Federal Register Website)

December 31, 2007

1.  Notice: Notice of Lodging of Proposed Consent Decree Under the Clean Water Act (Merck & Co.)

2.  Notice: In the Matter of Certain Systems for Detecting and Removing Viruses or Worms, Components Thereof, and Products Containing Same; Notice of Investigation

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

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

January 4, 2008

1.  National Drug Code Directory Download (updated 1/4/2008)

2.  National Drug Code Directory Search (updated 1/4/2008)

January 3, 2008

1.  Resolved Drug Shortage: Tc99: Multiple diagnostic products which utilize Tc99 generators (1/4/2008)

2.  FDA receives new data on risks of anemia drugs known as erythropoiesis-stimulating agents, or ESAs. FDA News | Communication about an Ongoing Safety Review (1/3/2008)

January 2, 2008

1.  Drugs@FDA Downloadable Data Files (updated 1/2/2008)

December 31, 2007

1.  FDA warns consumers not to use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai Chaojimengnan). MedWatch Safety Information (12/31/2007)

2.  Best Pharmaceuticals for Children Act of 2007: List of Determinations including Written Request (updated 12/31/2007)

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