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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The US FDA's Office of New Drugs wants external stakeholder oversight to accompany standardization and other internal efforts to ensure reviewer consistency after its reorganization.

Peter Stein, announced as OND director on Dec. 7 (see sidebar), recently listed four items that should help avoid a...

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