--------- September 23 - 07 ---------

 

+++ PharmCast.com's Company Highlight+++

HNC Products Inc. is an international R&D and custom dermatological care company centrally located in Clinton, Illinois.  HNC Products provide formulation development, contract filling as well as clinical packaging and labeling for various topical preparations – Rx, OTC and cosmeceutical ointments, lotions, creams and gels –– in a cGLP/cGMP adherent environment.  Our specialty is metal tube filling as well as form, fill and seal sample packets.  Call us at 217-935-6845 or e-mail info@hncproducts.com.

http://www.pharmcast.com/BuyersGuide/HNCProducts/HNCComInfo.htm


 

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

1.  How to Monitor Clinical Trials for GCP Compliance, October 9-10, 2007, Costa Mesa, CA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=043&source=pharmcast
 

2.  Web Seminar: Process Analytical Technology; An All-Inclusive Look, October 16, 2007.  Speaker: Kendall Young, PhD Technical Director, Blue Sea Consulting Inc.  Organized by BenAstrum, Inc. Use promotional code PC1007 for 10% discount.

http://benastrum.com/10.html
 

3.  2nd Annual Pharmaceutical & Medical Device CME Grants, October 1-2, 2007, New Brunswick, NJ.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=81
 

4.  Pharma & Biotech Competitive Intelligence & Business Analysis Conference, October 1-2, 2007, New Brunswick, NJ.  Organized by Apaporis.

http://www.pharmabiotechci.com/
 

5.  Discovery Chemistry Congress, October 3-4, 2007, South San Francisco, CA.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/DiscChemCongress07/
 

6.  Microwave-Assisted Organic Synthesis (MAOS), October 3-4, 2007, San Francisco, CA.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/MAOS2007/
 

7.  Therapeutic Monoclonal Antibody Discovery, October 4-5, 2007, Boston, MA.  Organized by Marcus Evans.

http://www.marcusevansbb.com/antibody
 

8.  CEE Clinical Outsourcing Partnerships 2007, October 8-10, 2007, Bratislava, Slovak Republic.  Organized by NextLevel Pharma.

http://www.nextlevelpharma.com/ceeoutsourcing/index.html
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/Sept2007/Home090407OG.htm


1.  Sensitization of chemotherapeutic agent resistant neoplastic cells with a virus

2.  DNA or RNA encoding a recombinant dengue envelope protein

3.  Methods for sterilizing cross-linked gelatin compositions

4.  Method for obtaining a purified viral preparation

5.  Anti-CD45RB antibodies

6.  Drug therapy for Celiac Sprue

7.  Sulfur-modified zinc oxide

8.  Process for effecting the relaxation of muscles of a human by means of fragrance

9.  Process for producing a recombinant protein in a mycobacterium host plasmid pJAM2

10.  Materials and methods for the treatment of hypertension and angina

11.  Method for sequencing nucleic acid sequences without chain termination

12.  CE7-specific chimeric T cell receptor

13.  Therapeutic uses of Dunaliella powder

14.  Carrier system for specific artery wall gene delivery

15.  Compositions and methods for the treatment of cystic fibrosis

16.  Method for preparing technetium-labeled antimony sulfide nanocolloid

17.  Treatment of neurotic disorders

18.  Dendrimer fluid purification method

19.  Method for the prediction of the risk potential for cancerous diseases and inflammatory intestinal diseases and corresponding tests

20.  Medical adhesive and methods of tissue adhesion

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

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

September 21, 2007

1.  Notice: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pharmaceutical Development Study

2.  Notice: Agency Information Collection Activities: Proposed Collection; Comment Request; Radioactive Drug Research Committees

September 20, 2007

1.  Proposed Rule: Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine) (*Large Document, Linked Directly US Federal Register Website)

2.  Notice: Educational Workshops on Current Good Manufacturing Practices; Public Workshops

3.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations

4.  Notice: Changes to Patient Limitation for Dispensing or Prescribing Approved Narcotic Controlled Substances for Maintenance or Detoxification Treatment by Qualified Individual Practitioners

September 19, 2007

1.  Notice: Implementation of the Emerging Pathogens and Disinfection Hierarchy for Antimicrobial Products; Notice of Availability; Reopening of Comment Period

September 17, 2007

1.  Notice: Draft Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff on In Vitro Diagnostic Multivariate Index Assays; Reopening of the Comment Period

2.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices

3.  Notice: Determination of Regulatory Review Period for Purposes of Patent Extension; Fel-O-Vax[supreg] LvK/FIV Vaccine

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

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

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

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

September 21, 2007

1.  User Fee Billable Products Approved Under Section 351 of the PHS Act - Update (Posted: 9/21/2007)

2. New Cells for New Vaccines II - 9/19/2007 (Posted: 9/21/2007)
    a. US Regulatory Perspective on New Cell Substrates for Manufacture of Viral Vaccines (PDF - 151 KB) - Arifa S. Khan, PhD

3.  Influenza Virus Vaccine 2007/2008 Season Lot Release Status - Update (Posted: 9/21/2007)

September 19, 2007

1.  Drugs@FDA Downloadable Data Files (updated 9/19/2007)

September 18, 2007

1. FDA Clears for Marketing First Rapid Test to Screen for Bacterial Contamination in Blood Platelets (Posted 9/18/2007)

2.  FDA launches the first issue of the FDA Drug Safety Newsletter, a publication for healthcare professionals and the medical community. (9/18/2007)

3.  SOPP 8117: Issuing Submission Numbers in Advance of the Receipt of the Electronic Submission (Posted: 9/18/2007)

4.  Approved Active Moieties That Have Appeared On The National Institutes Of Health’s (NIH) Annual Priority List For Which FDA Has Issued A Written Request For Pediatric Studies Under The Best Pharmaceuticals For Children Act (BPCA) (updated 9/18/2007)

September 17, 2007

1.  FDA issues an Alert on the risk of QT prolongation and Torsades de Pointes (TdP) in patients treated with Haldol (haloperidol). Drug Information (9/17/2007)

2.  New PDUFA payment procedures for application and supplement fees effective October 1, 2007 (9/17/2007)

3.  Drug Shortage; Drug to be Discontinued; Ethmozine (moricizine hydrochloride) 200mg, 250g, and 300mg tablets (updated 9/17/2007)

4.  FDA Licenses 15 New Blood Typing Tests - 9/14/2007 (Posted 9/17/2007)

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

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

1.  Kunshan Chemical & Pharmaceutical Company (Site Inspection)

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