Comment from Halloran Consulting Group
AnonymousSupportBusiness
Summary: Halloran Consulting Group provides specific feedback and requests for clarification on the draft guidance for master protocols in drug and biological product development. They suggest adding more practical details, such as FAQs, diagrams, and specific guidance on data integrity, multi-sponsor relationships, and international harmonization.
Please refer to attached comments to draft guidance from Halloran Consulting group. The document has been provided in .docx and .pdf format for convenience of the reviewers.