ePT--the Electronic Newsletter of Pharmaceutical Technology, Sep 15, 2011 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Sep 15, 2011
News
FDA and Department of Health Address Drug Shortages
By Angie Drakulich
FDA Commissioner Margaret Hamburg and US Assistant Secretary for Health Howard Koh released a statement aimed at a stakeholder meeting being held at the US Department of Health and Human Services to address the growing issue of drug shortages in the United States.
ISPE to Publish Updated Sterile-Product Manufacturing Guide
By Erik Greb
The International Society for Pharmaceutical Engineering will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide and contain practical information about technological advances in sterile manufacturing.
European Commission Consults on Pharmacovigilance
By Stephanie Sutton
The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission's 2010 amended pharmacovigilance legislation.
Novo Nordisk Launches Diabetes Program in India
By Amy Ritter
Novo Nordisk announced the roll-out of its Changing Diabetes in Children program in India, making India the seventh country to participate.
Funding to Drive Nanoscale Technology for Healthcare
By Rich Whitworth
The UK's Technology Strategy Board has partnered with the Engineering and Physical Sciences Research Council to invest up to £9 million ($14.2 million) in grant funding with the aim of driving proof-of-concept ideas to pilot technology demonstration for healthcare.
Week of September 12, 2011: AmerisourceBergen Completes the Acquisition of IntrinsiQ; Xcelience Expands its Manufacturing and Packaging Services; and More
AmerisourceBergen Completes the Acquisition of IntrinsiQ; Xcelience Expands its Manufacturing and Packaging Services; and More.
Regulatory Roundup: FDA Makes Organizational Changes Within CDER
FDA Makes Organizational Changes Within CDER.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
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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