Regulatory Roundup, Week of Dec. 3, 2012

FDA releases guidance documents on PET drugs, labeling of OTC sunscreen, and the use of certain phthalates as excipients.

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: