ePT--the Electronic Newsletter of Pharmaceutical Technology, Jul 21, 2011 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Jul 21, 2011
News
FDA Issues Draft Guidance on Targeted Drug Therapies
By Angie Drakulich
FDA issued a draft guidance for industry comment on proposed policy for diagnostic tests used with targeted drug therapies, that is personalized medicine.
Bipartisan Bill Introduced to Encourage Generic Drug Use in Medicaid
By Amy Ritter
A bill introduced by Senators Scott Brown (R-MA), Ron Wyden (D-OR), and John McCain (R-AZ) on July 13, 2011, aims to encourage states to reduce Medicaid spending by offering financial incentives to substitute generic drugs for branded ones where possible.
Department of Homeland Security Revises Tiering Assignments Under Chemical-Site Security Measures
By Patricia Van Arnum
The DHS announced it has revised tiering assignments for several chemical facilities covered under DHS's Chemical Facility Anti-Terrorism Standards program, which requires chemical companies to develop and implement specific security plans for their facilities.
PEW Recommends Steps to Secure the Supply Chain
By Erik Greb
The pharmaceutical industry and US regulatory bodies have not responded adequately to the increasing level of outsourced manufacturing in countries such as China and India, according to a new white paper by the PEW Health Group.
Week of July 18, 2011: Amgen Resolves Patent Dispute with Teva; PharmaNet Development Group Names George Scott Vice-President of Bioanalytical Services; and More.
Amgen Resolves Patent Dispute with Teva; PharmaNet Development Group Names George Scott Vice-President of Bioanalytical Services; and More.
Regulatory Roundup: FDA Approves the Influenza Vaccine Formulation for the 2011-2012 Flu Season
FDA Approves the Influenza Vaccine Formulation for the 2011-2012 Flu Season.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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