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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...
- Director, Office of New Drugs
378 followers 356 connections. View mutual connections with peter. Welcome back. or. Experience. Merck. Rahway, New Jersey. - Raritan New Jersey. Education. - 1977 - 1981. View peter...
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Jun 13, 2016 · “The investigational agent MK-1293 represents Merck’s entry into insulin therapeutics and into treatments that may be useful for patients with type 1 diabetes, and we are pleased with these Phase 3 results,” said Peter Stein, M.D., vice president, late stage development, diabetes and endocrinology, Merck.
Apr 14, 2023 · 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.
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 ...
- Zachary Brennan
development, Dr. Stein joined CDER in 2016 as the OND Deputy Director. Before coming to FDA, he served as Vice President for late stage development, diabetes, and endocrinology at Merck
Jun 13, 2016 · Merck’s Januvia franchise is well known as a standard diabetes treatment, but MK-1293 would be the company’s first foray into insulin therapies, said Dr. Peter Stein, Merck VP of late...
