Four Rules For Being A Consistent US FDA Reviewer From Peter Stein
Four Rules For Being A Consistent US FDA Reviewer From Peter Stein
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The US FDA Office of New Drugs is adopting a new, flatter structure under the leadership of Peter Stein, who issued remarks on the matter at Biopharma Conference IV. He used the platform to explain some of the changes to come, and offered advice for cutting down on inconsistencies in information issued from the agency to reviewers.
Author: Derrick Gingery
Publisher: Pinksheet
- Description
During Biopharma Conference IV, likely future US FDA Office of New Drugs Director Peter Stein addressed questions surrounding reviewer consistency at the agency in the wake of its upcoming planned reorganization. Some attendees of the conference expressed concerns that this move to a flatter organizational structure may result in conflicting advice being offered by the OND to sponsors in clinical trials. Stein offered four general rules for creating and maintaining consistency at the office where he will soon take the lead.
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