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  1. Feb 14, 2024 · Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions...

  2. Experience. Director, Office of New Drugs, CDER/FDA. FDA. View Peter Steins profile on LinkedIn, the world’s largest professional community. Peter has 1 job listed on their profile....

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  3. Feb 28, 2023 · On Monday, Peter Stein, head of the FDAs office of new drugs, emailed staff about the departure. Further Reading. A “disgraceful decision:” Researchers blast FDA for approving...

  4. Jun 11, 2021 · In a June 7 briefing, Dr. Peter Stein, director of the Office of New Drugs at the FDA, defended that decision, noting that “the mechanism of [aducanumab] is relevant to all stages of...

  5. Feb 10, 2020 · Regulatory News | 10 February 2020 | Zachary Brennan. Peter Stein, director of the US Food and Drug Administrations (FDA) Office of New Drugs (OND) sat down with Focus at FDAs White Oak campus for an exclusive interview to discuss some of the criticism FDA has received in recent months with regard to the pace of its drug approvals and the ...

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