--------- November 12-06 ---------

 

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

1.  Pharmaceutical, Biopharmaceutical, and Biologics Quality Control Laboratories: A Regulatory Compliance Primer, November 28-29, 2006, Irvine, CA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=097&source=pharmcast
 

2.  Drug Development in India, November 16-17, 2006, Boston, MA.   Organized by Cambridge Healthtech Institute.

http://www.healthtech.com/2006/pci
 

3.  NanoBiotech World Congress, November 16-17, 2006, Boston, MA.  Organized by Select Biosciences Ltd.

http://www.NanoBiotechCongress.com
 

4.  Webinar: The DRA and Its Impact on Pharmaceutical Price Reporting: How to Prepare for the Unknown, November 20, 2006, 10:30 am ET.  Organized by Pharmaceutical Education Associates.

http://www.pharmedassociates.com/conference.aspx?ccode=wp103
 

5.  European FTO Congress, November 27-28, 2006, Munich, Germany.  Organized by C5.

http://www.c5-online.com/fto/pr01.htm
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2006/Oct2006/Home102406OG.htm


1.  Combined therapies for atherosclerosis treatment

2.  Lipophilic drug compositions

3.  Method and screening candidate compounds for drug against tumor

4.  Method for the production and purification of adenoviral vectors

5.  Methods and compositions for treating conditions of the eye

6.  Compartmentalized dosage form

7.  Method of identifying putative antibiotic resistance genes

8.  Treatments for contaminant reduction in lactoferrin preparations and lactoferrin containing compositions

9.  Autonomic nerve regulating agent

10.  Pharmaceutical composition comprising factor VII polypeptides and factor V polypeptides

11.  Hyaluronic acid in the treatment of cancer

12.  Rapidly disintegrating methylcellulose tablets

13.  Method of screening for agents inhibiting chloride intracellular channels

14.  Engineered superantigen for human therapy

15.  Bovine immunodeficiency virus (BIV) based vectors

16.  Malaria polypeptides

17.  Process for producing an oral sustained-release preparation of fasudil hydrochloride

18.  Method of cancer screening; method of cancer treatment; and method of diabetes treatment

19.  Methods for genetic analysis

20.  Drug targets in Candida albicans

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

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

November 9, 2006

1.  Notice: Watson Pharmaceuticals, Inc., and Andrx Corporation; Analysis of Agreement Containing Consent Orders to Aid Public Comment

2.  Proposed Rule: Bovine Spongiform Encephalopathy; Minimal-Risk Regions, Identification of Ruminants and Processing and Importation of Commodities

3.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses

November 8, 2006

1.  Notice: National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Draft NTP Briefs on Genistein and Soy Formula; Request for Public Comments

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

3.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit Information to the Center for Veterinary Medicine

4.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Use E-Mail To Submit A Study Protocol

5.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance For Industry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office Of New Animal Drug Evaluation

November 7, 2006

1.  Notice: Importer of Controlled Substances; Notice of Registration

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

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

November 9, 2006

1.  FDA alerts the public of a nationwide recall of 500mg strength store-brand acetaminophen caplets. FDA News (11/9/2006)

2.  Drug Drug Shortage: Current; Lymphazurin 1% injection (isosulfan blue) (11/9/2006)

3.  Recall of Home Access and Home Access Express HIV-1 Test System, Home Access Health Corporation (Posted: 11/9/2006; Notice Date: 10/6/2006)

November 8, 2006

1.  BPCA/Pediatric Exclusivity Statistics
    a.  Pediatric Exclusivity Statistics (updated 11/8/2006)
    b.  Written Requests Issued (updated 11/8/2006)

2.  Drugs@FDA Downloadable Data Files (updated 11/8/2006)

3.  Guidance for Industry: Comprehensive List of Guidance Documents (PDF, updated 11/8/2006)

4.  Guidance for Industry: New/Revised/Withdrawn List for 2006 (PDF, updated 11/8/2006)

November 7, 2006

1.  Recommendations for the Generation and Submission of Genomic Data - Preliminary Draft Concept Paper (11/7/2006)

2.  Cyber Letters for 2006 (updated 11/7/2006)

3.  New patient information sheet for Prezista (darunavir) (updated 11/7/2006)

4.  National Drug Code Directory (updated 11/7/2006)

5.  Cellular, Tissue and Gene Therapies Advisory Committee Meeting (Posted: 11/7/2006, Meeting Date: 11/20/2006)

6.  Licensed Products and Establishments List - Update (Posted: 11/7/2006, Updated through: 10/31/2006)

7.  Approved Biological NDA and ANDA Applications - Update (Posted: 11/7/2006, Updated through: 10/31/2006)

8.  Cleared Biological 510(k) Device Applications - Update (Posted: 11/7/2006, Updated through: 10/31/2006)

9.  Approved Biological Premarket Approval (PMA) Device Applications - Update (Posted: 11/7/2006, Updated through: 10/31/2006)

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

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

1.  Alcon Research, Inc. (NevanacTM (nepafenac ophthalmic suspension) 0.1%)
 

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