Four Rules For Being A Consistent US FDA Reviewer From Peter Stein
Amid concerns Office of New Drugs reorganization will result in sponsors receiving conflicting advice, new director offers several items already contemplated to prevent such problems.
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Ideally, the system will prevent some cell and gene therapy programs from slowing, CBER Director Peter Marks says.
US FDA's Office of New Drugs director Peter Stein explained that different review divisions take different approaches in their regulation of biosimilars, but feels their frameworks will become more unified as they gain experience in reviewing biosimilar programs.