--------- January 14-07 ---------

 

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

1.  ADME, PK/TK and Drug Metabolism in Drug Discovery and Development, January 29-30, 2007, Malvern, PA.

http://www.cfpie.com/showitem.aspx?productid=090&source=pharmcast
 

2.  Practical Methods for Project Management, February 5-6, 2007, Malvern, PA.

http://www.cfpie.com/showitem.aspx?productid=060&source=pharmcast
 

3.  Moving From Discovery Into Development, February 5-6, 2007, Malvern, PA.

http://www.cfpie.com/showitem.aspx?productid=018&source=pharmcast
 

4.  Current Good Laboratory Practices & Current Good Manufacturing Practices – A Basic Primer, February 5-7, 2007, Malvern, PA.

http://www.cfpie.com/showitem.aspx?productid=021&source=pharmcast
 

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

1.  Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries, February 7-9, 2007, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=077&source=pharmcast
 

2.  14th International Molecular Medicine Tri-Conference, February 27 -, March 2, 2007, San Francisco.  Organized by Cambridge Healthtech Institute.

http://www.tri-conference.com/
 

3.  Prescription Drug Pricing, March 15-16, 2007, New York, NY.  Organized by the American Conference Institute.

http://www.americanconference.com/rxpricing.htm
 

4.  CEE & CIS Clinical Development Conference, March 22- 23, 2007, Bratislava, Slovak Republic.  Organized by NextLevel Pharma.

http://www.nextlevelpharma.com
 

5.  Pharmaceutical Sales & Marketing Executive Congress, March 26-27, 2007, Atlantic City, NJ.  Organized by iiBIG.

http://www.iibig.com/P0701
 

6.  ManuPharma Summit, March 28-30, 2007, Monte-Carlo, Monaco.  Organized by Marcus Evans.

http://www.manupharmaeurope.com
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2006/Dec2006/Home122606OG.htm


1.  Method and system for myocardial infarction repair

2.  Nucleic acid and amino acid sequences relating to Streptococcus pneumoniae for diagnostics and therapeutics

3.  Microemulsions as precursors to solid nanoparticles

4.  Methods and compositions for diagnosing and predicting the behavior of cancer

5.  Assay procedure using fluorogenic tracers

6.  Method and composition for preventing or reducing the symptoms of insulin resistance syndrome

7.  Derivatives of growth hormone and related proteins, and methods of use thereof

8.  Hematopoietic stem cells and methods of treatment of neovascular eye diseases therewith

9.  Ringing nanogel compositions

10.  Methods for glucagon suppression using modified exendins

11.  Aqueous fludarabine phosphate composition

12.  Vaccine immunotherapy for immune suppressed patients

13.  Method for relative quantification of methylation of cytosine bases in DNA samples

14.  Method of protecting erythricytes, in particular for improvement of blood cytopenia

15.  Pharmacologically acceptable solvent vehicles

16.  Treatment of gastrointestinal infections

17.  Bovine immunodeficiency virus (BIV) based vectors

18.  Liposomes encapsulating anticancer drugs and use thereof in the treatment of malignant tumors

19.  Method for improving adsorption of a drug from ethylene oxide derivative

20.  West nile vaccine

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

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

January 12, 2007

1.  Proposed Rule: Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants (*Large Document, Linked directly to Federal Register website)

2.  Direct Final Rule: Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; Withdrawal

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

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

January 11, 2007

1.  Notice: Review of Foreign-Trade Zone Activity, Foreign-Trade Subzone 43D, Perrigo Company, Battle Creek Michigan (Ibuprofen-Pharmaceutical Products)

2.  Final Rule: Exchange Visitor Program--Professors and Research Scholars

January 10, 2007

1.  Notice: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays; Availability

January 9, 2007

1.  Notice: Medical Devices 101: An Educational Forum; Public Workshop

January 8, 2007

1.  Notice: International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics; Availability

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

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

January 11, 2007

1.  FDA proposes new measures to strengthen drug safety under the PDUFA reauthorized user fee program. FDA News (1/11/2007)

2.  CDER Data Standards Manual: Dosage Form (updated 1/11/2007)

3.  Steven L. Kagen, MD (Posted: 1/11/2007, Issued: 12/18/2006)

4.  INCELL Corporation, LLC (Text) (Posted: 1/11/2007; Issued: 12/6/2006)

January 10, 2007

1.  Fast Track Designation Request Performance - Updated (Posted: 1/10/2007)

2.  FDA notifies pharmaceutical companies to confirm or repeat analytic studies used in the approval of a number of drug products. Information (1/10/2007)

3.  BPCA/Pediatric Exclusivity Statistics:
     a. Pediatric Exclusivity Granted (updated 1/10/2007)

4.  Bioresearch Monitoring Information System (BMIS) File (1/10/2007)

5.  Meeting: FDA/DIA co-sponsored conference: Sharing Knowledge to Improve clinical Drug Development and Regulatory Decisions: Data/models of Diseases, Drugs, Placebo, Baseline, and Dropouts. January 24 and 25, 2007, Washington, DC, Washington Marriott Hotel. Meeting Information [External Site] (1/10/2007)

January 9, 2007

1.  Approved Biological NDA and ANDA Applications (Update Posted: 1/9/2007, Updated through: 12/31/2006)

2.  National Drug Code Directory Download (updated 1/9/2007)

3.  National Drug Code Directory Search (updated 1/9/2007)

4.  BPCA/Pediatric Exclusivity Statistics:
    a.  Breakdown of Requested Studies Report (updated 1/9/2007)
    b.  Pediatric Exclusivity Statistics (updated 1/9/2007)
    c.  Spectrum of Diseases/Conditions (updated 1/9/2007)
    d.  Written Requests Issued (updated 1/9/2007)

January 8, 2007

1.  International Conference on Harmonisation (ICH); Draft Guidance: E15 Terminology in Pharmacogenomics (PDF, Posted: 1/8/2007, Publish Date: 1/8/2007)

2.  Clinical Investigator Inspection List (1/8/2007)

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

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

1.  WellSpring Pharmaceutical Corporation (Dyrenium® (triamterene) Capsules)

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