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Feb 28, 2023 · On Monday, Peter Stein, head of the FDA’s office of new drugs, emailed staff about the departure. Further Reading. A “disgraceful decision:” Researchers blast FDA for approving...
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...
Feb 10, 2020 · Regulatory News | 10 February 2020 | Zachary Brennan. 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 ...
Feb 16, 2024 · Peter P. Stein, MD (DCDG) Office of Medical Policy Director M. Khair ElZarrad, PhD, MPH (DCDH) Office of Executive Programs Director Mary Beth Clarke (DCDI) Office of Translational Sciences...
Apr 14, 2023 · April 14, 2023. Drugs Regulatory Affairs. CDER’s Office of New Drugs (OND) Director Peter Stein is a nationally recognized leader in pharmaceutical research and development. Before joining the FDA in 2016 as OND deputy director he was a vice president at Merck Research Laboratories and formerly a vice president at Janssen.
Jun 22, 2021 · “We recognized this actually fit very well into that accelerated approval paradigm,” said Peter Stein, director of the FDA’s Office of New Drugs, in a Tuesday interview with STAT. “This was...
June 7, 2021. From: Peter Stein, MD, Director, Office of New Drugs/CDER/FDA. BLA # 761178. Applicant: Biogen Inc. Proprietary Name: Aduhelm. Established or Proper Name: Aducanumab-avwa....
