--------- May 6 - 07 ---------

 

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

Mallinckrodt Pharmaceuticals Outsourcing, a business unit of Tyco Healthcare, is a contract manufacturer specializing in high-quality solid dose and oral liquid finished products.  We draw on the knowledge and experience of over 3,000 professionals, whose skills span from product development and manufacturing solutions, all the way through to product launch.  Our facility is located in the United States and is FDA and DEA I-V compliant.

http://www.pharmcast.com/BuyersGuide/Mallinckrodt/MallinckrodtComInfo.htm



 

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

1.  The Drug Development Process-From Development to Approval, June 6-8, 2007, Costa Mesa, CA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=025&source=pharmcast
 

2.  NanoBiotech World Congress, November 13-14, 2007, Boston, MA.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/nanobiotech2007/
 

3.  Advances in Metabolic Profiling, November 13-14, 2007, Boston, MA.  Organized by Select Biosciences Ltd.

http://www.selectbiosciences.com/conferences/amp2007/
 

4.  Sales Force Effectiveness USA 2007, November, 2007, Venue TBC.  Organized by eyeforpharma.

http://www.eyeforpharma.com/salesusa07
 

5.  FDA/CMS Summit December TBA, 2007, Washington DC.  Organized by Windhover Information, Inc.

http://www.windhover.com
 

6.  Pharmaceutical Antitrust, May 15-16, 2007, New York, NY.  Organized by American Conference Institute.

http://www.AmericanConference.com/RXAntitrust
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2007/April2007/Home041707OG.htm


1.  Nicotinamide N-methyltransferase as a marker for colorectal cancer

2.  Stabilized bioactive preparations and method of use

3.  HA-1 antigen

4.  Polymeric nanoparticles including olfactive components

5.  Potent immunostimulants from microalgae

6.  Method for reducing artifacts in nucleic acid amplification

7.  Dietary supplement composition for ameliorating inflammatory changes in influenza process

8.  Streptococcus agalactiae vaccine

9.  High efficacy gel with low glycol content

10.  Genome mutation by intron insertion into an embryonic stem cell genome

11.  Treatment and control of dry eye by use of biodegradable polymer capsules

12.  Mixed Virus-like particles

13.  Porphyromonas gingivalis recombinant proteins and truncations

14.  Method of regulating transcription in a cell

15.  Process for the synchronization of ovulation for timed breeding without heat detection

16.  Hybrid peptides modulate the immune response

17.  Compositions and methods for the treatment of primary and metastatic neoplastic diseases using arsenic compounds

18.  Sodium bicarbonate/sodium chloride micronized slurry

19.  Methods of treating Alzheimer's disease and other amyloidoses using Hypericum perforatum and derivatives thereof

20.  Responsive microgel and methods related thereto

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

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

May 4, 2007

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

May 3, 2007

1.  Final Rule: Schedules of Controlled Substances: Placement of Lisdexamfetamine Into Schedule II

May 2, 2007

1.  Notice: Guidance for Industry on Testing of Glycerin for Diethylene Glycol; Availability

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

May 1, 2007

1.  Notice: Request for Applications for the Intergenerational Approaches to HIV/AIDS Prevention Education With Women Across the Lifespan Pilot Program

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

April 30, 2007

1.  Notice: Defining and Implementing Quality in Clinical Investigations: From Design to Completion; Public Workshop; Request for Comments

2.  Notice: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Valid or Will Not Be Infringed

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

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

May 4, 2007

1.  Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P): Alphabetical List of Registered Establishments - Updated (Posted: 5/4/2007)

2.  Manuals of Policies and Procedures (MAPPS) (Updated 5/4/2007)
    a.  4642.1R Policies and Procedures for Organizational Changes
    b.  4657-0R CDER's Time, Attendance, and Leave Recording Policy
    c.  4657.6R Granting Excused Absence (Originator: Division of Management Services, OM)
    d.  4657.11R Religious Compensatory Time
    e.  6020.2R Applications for Parenteral Products in Plastic Immediate Containers

May 3, 2007

1.  Drugs@FDA Downloadable Data Files (updated 5/3/2007)

May 2, 2007

1.  ApothéCure and FDA notify all healthcare professionals of recent deaths associated with the use of compounded injectable Colchicine. MedWatch Safety Information (5/2/2007)

2.  FDA proposes new warnings about suicidal thinking and behavior in young adults who take antidepressant medications. FDA News (5/2/2007)

3.  Drug Shortages (updated 5/2/2007):
    a.  Resolved: Ketalar CIII
    b.  Drug to be Discontinued: ProSom

May 1, 2007

1.  Presentations from the FDA/Small Business Administration Drug Educational Forum, April 25, 2007 (5/1/2007)

2.  Guidance for Industry: Testing of Glycerin for Diethylene Glycol [HTML] or [PDF] (Updated 5/1/2007)

3.  Guidance for Industry: Comprehensive List of Guidance Documents (PDF, updated 5/1/2007)

4.  New/Revised/Withdrawn List for 2007 (PDF, updated 5/1/2007)

5.  SOPP 8401: Administrative Processing of Biologics License Application (BLA) - Updated (Posted: 5/1/2007)

April 30, 2007

1.  FDA Approves Product to Treat Common Bleeding Disorder (Posted 4/30/2007)

2. Office of Generic Drugs:
    a.  Paragraph IV Patent Certifications (updated 4/30/2007)

3.  Drug Master Files (updated 4/30/2007)

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

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

1.  Robert Michael Murray, MD (BMIS Inspection)

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