Comment from Certara
AnonymousSupportBusiness
Summary: Certara, a pharmaceutical services company, supports the draft guidance on Master Protocols but requests several specific clarifications and additions. Their suggestions include expanding the scope to include combination therapies, providing more detailed examples of trial designs (like umbrella and platform trials), and clarifying regulatory requirements for IND submissions and data sharing.
Certara welcomes the opportunity to comment on the agency guideline, our comments are provided in the attached document.