--------- January 20 - 08 ---------

 

+++ PharmCast.com's Healthcare MBA Program Highlight+++

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http://mbahc.info/li/

 

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

1.  Project Management for Phase 1 & 2 Clinical Trials, February 11-12, 2008, Malvern, PA.  Organized by The Center for Professional Innovation & Education.

http://www.cfpie.com/showitem.aspx?productid=101&source=pharmcast
 

2.  Essentials of Microbiological Testing (Classroom). Organized by USP (United States Pharmacopeia).

http://www.usp.org/goto/phcmicro
 

3.  Web Seminar: GMPs in Microbiology; the QSIT Approach, February 12, 2008.  Speaker: Ziva Abraham.  Organized by BenAstrum, Inc. (Use promotional code PC0208 for 10% discount)

http://www.benastrum.com/index.php?option=com_content&task=view&id=39&Itemid=69
 

4.  The 2nd Annual Skin Summit: Transdermal drug development and delivery, biotechnology, cosmeceuticals, and skin, February 20-21, 2008, Philadelphia, PA.  Organized by Financial Research Associates.

http://www.pharmedassociates.com/conference.aspx?ccode=p675
 

5.  7th Successful, Compliant Investigator-Initiated Trials, February 21-22, 2008, Miami, FL.  Organized by ExL Pharma.

http://www.exlpharma.com/eventDetail.php?id=99
 

6.  Positioning Pharmaceutical Brands for Maximum Value, Feb. 25-26, 2008, Philadelphia, PA.  Organized by Strategic Research Institute.

http://www.almevents.com/pharmabrand
 

7.  Global Biopharmaceutical Outsourcing and Clinical Trials Workshop Feb. 25-26, 2008, Philadelphia, PA.  Organized by Strategic Research Institute.

http://www.almevents.com/globaloutsource
 

8.  Pharmaceutical Packaging and Labelling Innovations, February 25-26, 2008, London, United Kingdom.  Organized by SMi Group Ltd.

http://www.smi-online.co.uk/08pharmapackaging.asp
 

9.  Strategic Healthcare Resource Management, February 25-26, 2008, Bangkok Thailand.  Organized by Marcus Evans.

http://www.marcusevans.com/html/eventdetail.asp?eventID=13244&SectorID=27&divisionID=
 

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

http://www.pharmcast.com/PatentToSubWeb/Yr2008/Jan2008/Home010108OG.htm
 

1.  Nanoemulsion vaccines

2.  Biochemical test for identifying pregnancies with Down's syndrome fetus

3.  Constructs and methods for expression of recombinant HCV envelope proteins

4.  Modified vitamin K-dependent polypeptides

5.  AAv scleroprotein, production and use thereof

6.  PRP composition and minimally invasive method for treating myocardial infarction

7.  Soft capsule preparation

8.  Polypeptides containing polymorphisms of the repeated regions of pertactin in Bordetella pertussis, Bordetella parapertussis, and Bordetella bronchiseptica, their use in diagnostics, and in immunogenic compositions

9.  Method for selecting therapeutic agents for cancer

10.  Method of effecting a change in a cell, and a vector

11.  Cationic lipid-mediated enhancement of nucleic acid immunization of cats

12.  Apolipoprotein biopolymer markers indicative of insulin resistance

13.  Humanin, a polypeptide suppressing neuronal death

14.  Recombinant monoclonal antibodies and corresponding antigens for colon and pancreatic cancers

15.  Method of administering liposomal encapsulated taxane

16.  Multi-marker screening protocol for fetal abnormalities

17.  Biodegradable injectable implants containing glycolic acid

18.  Heparin-like compounds, their preparation and use to prevent arterial thrombosis associated with vascular injury and interventions

19.  Formulation and process for drug loaded cores

20.  Ctage gene family

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

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

January 18, 2008

1.  Notice: Draft Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

2.  Proposed Rule: Registration Requirements for Importers and Manufacturers of Prescription Drug Products Containing Ephedrine, Pseudoephedrine, or Phenylpropanolamine

January 16, 2008

1.  Proposed Rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices

2.  Notice: Animal Cloning Risk Assessment; Risk Management Plan; Guidance for Industry; Availability

3.  Notice: User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products; Program Will Not Be Implemented

January 15, 2008

1.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)

2.  Notice: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions

3.  Notice: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, FDA Form 3602A

January 14, 2008

1.  Notice: Food and Drug Administration's Transition to the Federal Dockets Management System

January 11, 2008

1.  Proposed Rule: Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Extension of Comment Period

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

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

January 18, 2008

1.  Biological Product Shortages - Yellow Fever Vaccine (Posted: 1/18/2008)

January 17, 2008

1.  American Course on Drug Development and Regulatory Sciences - 1/10/2008 (Posted 1/17/2008)
    a.  Vaccine Safety: An FDA Perspective (PDF - 129 KB) - Karen Midthun, MD

2.  FDA Approves First Clotting Solution Made Using Recombinant DNA Technology (Posted 1/17/2008)

3.  FDA issues a Public Health Advisory recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years. FDA News | Public Health Advisory (1/17/2007)

January 16, 2008

1.  FDA issues a Federal Register notice [HTML] [PDF] to inform companies that the Direct-to-Consumer (DTC) television advertisement user fee program will not commence. (1/16/1008)

2.  FDA issues a Public Health Advisory on edetate disodium (marketed as Endrate and generic products) (1/16/1008)

3.  BPCA/Pediatric Exclusivity Statistics (updated 1/16/1008):
    a.  Breakdown of Requested Studies Report
    b.  Pediatric Exclusivity Labeling Changes
    c.  Spectrum of Diseases/Conditions
    d.  Written Requests Issued
    e.  Written Requests Statistics

January 15, 2008

1.  Cyber Warning Letters (updated 1/15/2008)

2.  FDA approves Tysabri (natalizumab) to treat moderate-to-severe Crohn's Disease. (1/15/2008)

3.  Inactive Ingredients for Approved Drug Products (Search) (updated 1/15/2008)

4.  Inactive Ingredients for Approved Drug Products (Download) (updated 1/15/2008)

5.  Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated) (updated 1/15/2008)

January 14, 2008

1.  Office of Generic Drugs (updated 1/14/2008):
    a.  Paragraph IV Patent Certifications
    b.  December First-Time Generic Drug Approvals
    c.  Suitability Petitions

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

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

1.  Wyeth Pharmaceuticals, Inc. (Effexor XR© (venlafaxine HCI) Tablets)

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