--------- April 22 - 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.  Process Validation for Medical Devices May 7-9, 2007, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=089&source=pharmcast
 

2.  PharmaForce 2007: The Premier North American Pharmaceutical Sales Force Effectiveness Conference, September 17-19, 2007, Philadelphia, PA.  Organized by Worldwide Business Research.

http://www.wbresearch.com/pharmaforceusa/index.asp?cm_mmc=Affiliate-_-Listing-_-11869.001-_-PharmCast
 

3.  LogiPharma 2007, September 17-19, 2007, Philadelphia, PA .  Organized by Worldwide Business Research.

http://www.logipharma.com
 

4.  RNAi Europe, September 19-21, 2007, Barcelona, Spain.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/rnaieurope07/index.aspx
 

5.  2nd Annual Leadership Summit on Revenue Cycle Innovations September 27-28, 2007, Washington, DC.  Organized by World Congress. ($400.00 discount to PharmCast.com's visitors; use code: JZE558)

http://www.worldcongress.com/revenuecycle
 

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

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

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/April2007/Home040307OG.htm


1.  Compositions and methods for the generation of protective immune responses against malaria

2.  Formulations for transdermal or transmucosal application

3.  ICBP90 polypeptide and its fragments and polynucleotides coding for said polypeptides and applications for diagnosing and treating cancer

4.  Antiobestic agents and health foods

5.  Method of treatment for spinal cord injury

6.  Sustained release oral preparations

7.  Antifungal parenteral products

8.  Systems and methods related to degradation of uremic toxins

9.  Recombinant promoters in avian cells

10.  Compositions for the relief of xerostomia and the treatment of associated disorders

11.  Nucleic acid and amino acid sequences of infectious salmon anaemia virus and their use as vaccines

12.  Use of treprostinil to improve kidney functions

13.  In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate of nanoparticulate active agent compositions

14.  Crude drug composition for preventing and treating gastrointestinal dyskinetic diseases

15.  Drug sensitivity measuring method

16.  Non-invasive localization of a light-emitting conjugate in a mammal

17.  Genetic immunization against cervical carcinoma

18.  Methods and compositions for obtaining mature dendritic cells

19.  Myeloid precursor cell useful for gene therapy and for modulation of immune responses

20.  Binding domains between presenilins and their substrates as targets for drug screening

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

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

April 20, 2007

1.  Notice: Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting

2.  Notice: Approval for Expansion of Subzone 208A, and of Expanded Manufacturing Authority, Pfizer Inc (Pharmaceutical Products), Groton, Connecticut

April 19, 2007

1.  Notice: Withdrawal of Approval of New Animal Drug Applications; Estradiol Benzoate

2.  Notice: Withdrawal of Approval of New Animal Drug Applications; Pyrantel; Tylosin; Tylosin and Sulfamethazine

April 18, 2007

1.  Notice: Statement of Organization, Functions, and Delegations of Authority

April 16, 2007

1.  Notice: National Toxicology Program (NTP); Report on Carcinogens Review Process for the 12th Report on Carcinogens (RoC)

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

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

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

April 20, 2007

1.  Vaccine Safety Workshop - 4/10-11/2007 (Posted 4/20/2007)
    b.  Vaccine Safety: Vision for the Future (PDF - 111 KB) - Jesse L. Goodman, MD, MPH

April 19, 2007

1.  World Vaccine Congress - 3/20/2007 (Posted 4/19/2007)
     a.  Vaccine Regulation: FDA’s Role in Facilitating Development of and Access to New Vaccines (PDF - 253 KB) - Karen Midthun, MD

2.  Office of Generic Drugs:
     a.  FDA addresses issues on Amlodipine Abbreviated New Drug Application Approvals (4/19/2007)

3.  E-08 Product Quality Lifecycle Implementation: Practical Approach to QbD - co-sponsored by the FDA, June 6-7, 2007, Arlington, VA. Meeting Information (4/19/2007)

4.  Current Drug Shortage: Indocyanine Green for Injection, USP (IC-GREEN) (updated 4/19/2007)

April 18, 2007

1.  SOPP 8413: Postmarketing Commitment Related Submissions – Administrative Handling, Review, and CBER Reporting - Updated (Posted: 4/18/2007)

April 17, 2007

1.  Draft Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting - Improving Human Subject Protection (PDF - 75 KB) (Posted 4/17/2007)

2.  Drug Approval Report: CDER Response to Request for "Fast Track" Designation FY 2007 (4/17/2007)

3.  FDA Approves First U.S. Vaccine for Humans Against the Avian Influenza Virus H5N1 (Posted 4/17/2007)

4.  H5N1 Influenza Virus Vaccine Questions and Answers (Posted: 4/17/2007)

5.  CDER Key Officials (PDF, updated 4/17/2007)

April 16, 2007

1.  AdvaMed Meeting - Slide Presentation (3/9/2007 , Posted: 4/16/2007)
     a.  CBER 2007: Update and Priorities (PDF - 461 KB) - Jesse L. Goodman, MD, MPH

2.  SOPP 8114 - Administrative Processing of Documents Received Prior to Submitting Investigational or Marketing Applications (Pre-Application) (Posted: 4/16/2007)

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