On Monday, December 13th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Q13 Continuous Manufacturing of Drug Substances and Drug Products. The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH) and provides clarification on continuous manufacturing (CM) concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products. According to the Agency, the draft guidance is intended to provide scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of CM. In the comments submitted, BIO recommended the inclusion of additional terms in the guidance’s glossary, offered suggestions of where it might be helpful for the Agency to include specific examples, and requested the revision or addition of language to further clarify a handful of key points.

BIO is committed to enhancing clinical trial diversity as part of our BIOEquality Agenda published in the fall of 2020. During the pandemic we witnessed biopharmaceutical companies achieve increased clinical trial diversity through commitment and regulatory acceptance of certain clinical development tools and approaches. We appreciate the opportunity to provide feedback on the draft legislation.