After REMS: An Interview With Amgen’s Paul Seligman

Health care reform means a lot of things for the pharmaceutical industry. Will it also mean the end of REMS? The former head of FDA’s drug safety office thinks that is a question worth asking.

If you are interested in the future of pharmaceutical risk management, you might want to start by reading a 15-year-old report.

In an interview on the evolution of FDA’s Risk Evaluation & Mitigation Strategies, Amgen Inc. Executive Director-Global Regulatory Policy Paul Seligman brought with him a copy of the 1999 report by FDA’s task force on risk management for medical products

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