Regulatory Roundup, Week of Dec. 3, 2012

Dec 05, 2012
By PharmTech Editors

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: