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Type: Peer Reviewed Publications

Achieving the goals of effective, safe, and individualized cancer care.

Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.

Reducing the toxicity of cancer therapy: recognizing needs, taking action.

Considerations for the successful co-development of targeted cancer therapies and companion diagnostics.

Use of multiple endpoints and approval paths depicts a decade of FDA oncology drug approvals.

Developing standards for breakthrough therapy designation in oncology.

Regulatory watch: Impact of breakthrough therapy designation on cancer drug development

A Century of Medical Product Regulation: The Historic Framework for Medical Product Regulation