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

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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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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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View Results
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Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
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Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests

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