Regulatory News - November 2017

ICH Guidance on CTD M4 Organization
The ICH Guidance on "M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use" dated October 2017 is available now at:
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugsgen/documents/document/ucm073257.pdf

Pharmacovigilance Special Interest Group Updates

The PV SIG webpage was updated with regard to news, sources, and links relevant for pharmacovigilance writers (status: September 2017). Visit the tabs “News” and “Resources”! Draft updated guidance on REMS format and content has been published in early October by the US FDA. The draft revises 2009 draft guidance for an industry known as "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications." You can find further information here.