ePT--the Electronic Newsletter of Pharmaceutical Technology, Sep 1, 2011 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Sep 1, 2011
News
FDA Publishes Draft Guidance on Tablet Scoring
By Erik Greb
FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for scored tablets.
EMA to Apply New Electronic Submission Validation Criteria
By Rich Whitworth
EMA announced that a new version of the validation criteria for electronic applications for human medicines comes into effect on Sept. 1, 2011.
USP and Brazil Partner on Public Health Education
By Angie Drakulich
USP and the Brazilian National Agency of Sanitary Surveillance are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil.
Week of August 29, 2011: Valeant Agrees to Acquire Afexa Life Sciences; Merck KGaA Names Robert Yates President of Millipore Division; and More
Valeant Agrees to Acquire Afexa Life Sciences; Merck KGaA Names Robert Yates President of Millipore Division; and More.
Regulatory Roundup: African Community Joins ICH's Steering Committee
African Community Joins ICH's Steering Committee.

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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 LangerRelationship-building at Top of Mind for Clients
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Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
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