Date:
Fri, March 23, 2007 08:27:48 PMFrom:
PharmCast Dot Com
Subject:
PharmCast.com's Official Newsletter, March 25, 2007
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P H A R M C A S T D O T C O M
The www.PharmCast.com Official
Newsletter
--------- March 25 - 07 ---------
+++ CfPIE's Pharmaceutical/Biotech Training Courses Highlight+++
1. Adverse Drug Events - Understanding and Reporting Requirements, April 12-13, 2007, Malvern, PA.
http://www.cfpie.com/showitem.aspx?productid=002&source=pharmcast
2. Selecting & Managing CRO's, April 12-13, 2007, Malvern, PA.
http://www.cfpie.com/showitem.aspx?productid=086&source=pharmcast
3. FDA Inspections - What to Expect and How to Prepare, April 23-24, 2007, Malvern, PA.
http://www.cfpie.com/showitem.aspx?productid=033&source=pharmcast
+++ PharmCast.com's Conference Highlight
+++
1. Effective Risk-Based Applications of cGMPs for Cosmetics and OTC Drug Products, April 23-24, 2007, Malvern, PA. Organized by The Center for Professional Innovation & Education.
http://www.cfpie.com/showitem.aspx?productid=037&source=pharmcast
2. 6th Annual European Drug Discovery Partnerships, May 15-16, 2007, Berlin, Germany. Organized by Informa Life Sciences.
http://www.informa-ls.com/drugdelivery
3. CHI's Global R&D Congress: Strategic Planning for Discovery, Development and Clinical Operations in China, India and other Emerging Regions, May 15-16, 2007, Philadelphia, PA. Organized by Cambridge Healthtech Institute.
http://www.healthtech.com/2007/PCG
4. Advances in Microarray Technology, May 15-16, 2007, Edinburgh, UK. Organized by Select Biosciences Ltd.
http://www.selectbiosciences.com/conferences/AMT2007
5. Lab-on-a-Chip World Congress (Life Science Applications), May 15-16, 2007, Edinburgh, UK. Organized by Select Biosciences Ltd.
http://www.selectbiosciences.com/conferences/loac2007
6. SEQNSYNTECH (Advances in Nucleic Acid Sequencing & Synthesis), May 15-16, 2007, Edinburgh, UK. Organized by Select Biosciences Ltd.
http://www.selectbiosciences.com/conferences/SEQNSYNTECH2007
+++ PharmCast.com's Last Week
Pharmaceutical Patents +++
http://www.pharmcast.com/PatentToSubWeb/Yr2007/Mar2007/Home030607OG.htm
1. Neural stem cells and use thereof for brain tumor therapy
2. Vaccines absorbable by the transmucosal way
3. Modulating transcription of genes in vascular cells
4. Stable pharmaceutical compositions containing 7-substituted-3,5-dihydroxyheptanoic acids or 7-substituted-3,5-dihydroxyheptenoic acids
5. Prevention of brain damage in stroke
6. Method for preparing human immunoglobulin concentrates for therapeutic use
7. Composition and use of RAR antagonists for promoting chondrogenesis
8. Method of extracting virus from cell culture
9. Hydrogels and water soluble polymeric carriers for drug delivery
10. Cancerous disease modifying antibodies
11. Dry powder for inhalation
12. Determining the effect of a substance on sequestration, uptake, and accumulation of amyloid in brain cells
13. High level expression of immunogenic proteins in the plastids of higher plants
14. Treatment of optic and otic inflammation
15. Nimesulide gel systems for topical use
16. Methods of producing neurons
17. Method of treating leishmaniasis using methyl-beta-cyclodextrin
18. Methods for targeted drug delivery
19. Preventative and treatment effects of Morinda citrifolia on diabetes and its related conditions
20. Multi-part substitution infusion fluids and matching anticoagulants
+++ PharmCast.com's Last Week Federal
Register +++
http://www.pharmcast.com/FederalRegistrar/FRHome.htm
March 23, 2007
1. Notice: Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees; Availability
March 22, 2007
1. Notice: Request for Nominations for Voting Members on Public Advisory Committees
2. Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and Drug Administration Rapid Response Surveys
March 20, 2007
1. Notice: Office of the Assistant Secretary for Preparedness and Response; HHS Public Health Emergency Medical Countermeasures Enterprise Strategy for Chemical, Biological, Radiological and Nuclear Threats
March 19, 2007
1. Notice: Draft Guidance for Industry on Indexing Structured Product Labeling; Availability
+++ PharmCast.com's Last Week Recent FDA
Links +++
http://www.pharmcast.com/FDALinks/FDALinksLatest.htm
March 23, 2007
1. The Evolution of Drug Master Files (DMFs) -
Drug Information Association - 3/19/2007 (Posted 3/23/2007)
a. Drug Master Files - CBER Processes and Review (PDF -
156 KB) - Jay Eltermann, R.Ph., M.S.
2. Guidance for Industry and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees [PDF] (3/23/2007)
March 22, 2007
1. Drugs@FDA Downloadable Data Files (updated 3/22/2007)
March 21, 2007
1. Postmarketing Monitoring of Intussusception After RotaTeq Vaccination --- United States, February 1, 2006--February 15, 2007 (MMWR) - 3/16/2007 (Posted: 3/21/2007)
2. Influenza Virus Vaccine 2007-2008 Season (Posted: 3/21/2007)
March 20, 2007
1. Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated 3/20/2007)
2. Office of Generic Drugs:
a. Approved Discontinued Drug Products Safety and
Effectiveness Determinations (PDF, 3/20/2007)
March 19, 2007
1. Cosmos Trading, Inc. and FDA notify consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name Rhino Max. MedWatch Safety Information (3/19/2006)
2. Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2007 (updated 3/19/2007)
+++ PharmCast.com's Recent FDA Warning Letters +++
http://www.pharmcast.com/WarningLetters/LatestWL.htm
1. Takeda Pharmaceuticals North America, Inc. (Rozerem (ramelteon) Tablets)
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