Regulatory Roundup, Week of Dec. 3, 2012 - Pharmaceutical Technology

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PharmTech Europe

Regulatory Roundup, Week of Dec. 3, 2012


The International Conference on Harmonization (ICH) has announced that the Steering Committee has endorsed a revision of both the S1 Concept Paper and Business Plan. The revised documents include the S1 strategy to prepare a draft “Regulatory Notice for Public Input” for the solicitation of public comments with a final notice to be published in June 2014. 

FDA has released the following guidance documents:

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What impact do mega-mergers of biopharmaceutical companies have on the development of new drugs?
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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerSeeking Alternative Catalyst Solutions
Jill Wechsler Regulatory Watch Jill Wechsler Global Expansion Shapes Drug Oversight
Chris Burgess Statistical Solutions Chris BurgessIs a Sample Size of n=6 a Magic Number?
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Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
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USP Faces New Challenges
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