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Regulatory Sciences Headlines

Pharmaceutical Firms Thriving As Prices Climb
Vietnam Economic Times (12/24/07)

Validating the Feasibility of Using Stem Cells for Drug Discovery
Chemical Online (12/04/07)

FDA Issues Complete Response Letter for Paliperidone Palmitate for the Treatment of Schizophrenia
MarketWatch (08/26/08)

Medco Health, FDA to Study Role of Genetics in Prescribing Drugs
Wall Street Journal (08/19/08)

Drug Safety Oversight Board Meeting: June 19, 2008, Public Summary
FDA.gov (07/28/08)

FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
FDA.gov (07/17/08)

2008 PDA/FDA Joint Regulatory Conference
PDA.org (07/15/2008)

MHRA Issues Further Warning on Varenicline
Pulse (07/10/08)

Harnessing Helices
Chemical & Engineering News (06/02/08) Vol. 86, No. 22, P. 18

Information for Healthcare Professionals Mycophenolate Mofetil (Marketed as CellCept) and Mycophenolic Acid (Marketed as Myfortic)
FDA.gov (05/16/08)

Purdue's New OxyContin Formulation Faces Advisory Committee Skepticism
FDA News Drug Daily Bulletin (05/07/08) Vol. 5, No. 90,

Wider Use of Cephalon Drug Too Risky: U.S. Advisers
Reuters (05/06/08) P. Wider

Human Subject Protection: Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
Federal Register (04/28/08) Vol. 73, No. 82,

Trying Times at the FDA: The Challenge of Ensuring the Safety of Imported Pharmaceuticals
New England Journal of Medicine (04/24/08) Vol. 358, No. 17, P. 1773

FDA Extends Review Period for Amgen's Nplate
Pharma Times World News (04/09/08)

Regulating Off-Label Drug Use: Rethinking the Role of the FDA
New England Journal of Medicine (04/03/08) Vol. 358, No. 14, P. 1429

Dynavax, Merck: FDA Puts Clinical Hold On HEPLISAV Vaccine
Dow Jones Newswires (03/17/08)

EMEA Reports Strong Performance in Regulatory and Public-Health Activities in 2007
European Medicines Agency (03/10/2008)

FDA Concerned About Some STD Medications
United Press International (03/10/08)

U.S. FDA Staff Seeks Input on Amgen Clot Drug Risks
Scientific American (03/08)

BioDelivery Sciences to Expand Research for Breakthrough Pain Drug
Wral.com (01/15/08)

FDA Caution, 'Research Drought' Cuts Drug Approvals
USA Today (01/05/08)

Chinese Generic Makers Snapping at the Heels of Indian Counterparts: Industry Insiders
Interfax News Agency-China (11/23/07)

Small Cap: Bionics to Test Anti-Cancer Drug on Humans
Australasian Investment Review (11/22/07)

Novartis Drug Gets EU Approval
Wall Street Journal (10/01/07) P. B6



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