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      • Peter Stein is the Deputy Director, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). He earned his medical degree from University of Pennsylvania and trained at Yale-New Haven Hospital in internal medicine, and in endocrinology and metabolism.
      reaganudall.org/leveraging-real-world-treatment-experience-ea-protocols#:~:text=Peter%20Stein%20is%20the%20Deputy%20Director%2C%20Office%20of,in%20internal%20medicine%2C%20and%20in%20endocrinology%20and%20metabolism.
  1. Peter Stein | FDA

    www.fda.gov/.../peter-stein

    Oct 22, 2019 · Peter Stein M.D. 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 ...

  2. CDER Leadership Bios | FDA

    www.fda.gov/about-fda/center-drug-evaluation-and...

    Peter Stein, M.D. Director, Office of New Drugs. Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational ...

  3. Office of New Drugs | FDA

    www.fda.gov/about-fda/center-drug-evaluation-and...

    Drugs@FDA includes most of the drug products approved since 1939. Drug Application and Approval Process - "Questions and Answers" Frequently asked questions and answers about the drug application ...

  4. Peter P. Stein, M.D. Deputy Director, Office of New Drugs ...

    www.jhsph.edu/.../news-and-events/SteinPDF.pdf

    Peter P. Stein, M.D. Deputy Director, Office of New Drugs, Center for Drug Evaluation and Research’ Food and Drug Administration Peter earned his medical degree from University of Pennsylvania and trained at Yale-New Haven Hospital in internal medicine, and in endocrinology and metabolism. He was on faculty at Yale in the Section of

  5. Interview With FDA’s OND Director: Approval Standards ...

    www.raps.org/news-and-articles/news-articles/...

    Peter Stein, director of the US Food and Drug Administration’s (FDA) Office of New Drugs (OND) sat down with Focus at FDA’s 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 possible lowering of its approval standards.

  6. The FDA’s COVID-19 Shakeup - PharmaBoardroomPharmaBoardroom

    pharmaboardroom.com/articles/the-fdas-covid-19...

    Taking part in the discussion on June 11 th 2020 were Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the FDA and Peter Stein, director of the Office of New Drugs (OND) under the Center for Drug Evaluation and Research (CDER). Hosting the talk was Richard Pops, chairman and CEO of Alkermes.

  7. Pink Sheet - US FDA Office Of New Drugs Likely To Be Headed ...

    www.focr.org/news/pink-sheet-us-fda-office-new...

    Nov 20, 2018 · Peter Stein is a familiar face within OND and has been working alongside CDER Director Janet Woodcock on the proposed “modernization” of OND. As a previous recruit from outside FDA, Stein has had time to make the key connections and adjustments to working inside government.

  8. Brief overview of biomarkers: value, limitations, and the ...

    fnih.org/sites/default/files/final/pdf/2-Stein...

    Peter Stein, MD. Deputy Director. Office of New Drugs / CDER / FDA. Disclaimers • Views expressed in this presentation are those of the speaker and do not necessarily

  9. Shakeup at the Top of FDA’s Biosimilars Division | RAPS

    www.raps.org/news-and-articles/news-articles/...

    The US Food and Drug Administration (FDA) on Friday announced that Leah Christl, director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs (OND), has decided to leave FDA and will depart 22 February. Christl is moving to Amgen.<br />

  10. Peter Stein, Boss of the Beach in NYC

    nymag.com/intelligencer/2020/06/peter-stein-nyc...

    Peter Stein (left, circled) with lifeguards and the head of the Parks Department in 1996. Rockaway Beach lifeguard-competition team (right) in 1984.Joe McManus, third from right in the back