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Friday, January 20, 2017

FDA Begins Cancer Product Review Center (note: comment ovarian cancer)

science news
  January 20th, 2017
The Oncology Center of Excellence aims to better coordinate evaluations of new therapeutic products for cancer by the FDA’s separate offices for drugs, biologics, and medical devices. While applications and review criteria for new treatments and devices are not expected to change, FDA says the new center plans to draw more on the expertise of scientific and regulatory professionals in these offices, where needed, and encourage more collaboration across the usual hierarchies.

In an agency blog post after his appointment in June, Pazdur noted the oncology center will emulate models from cancer care facilities and the academic world that put more emphasis on multi-disciplinary collaboration to confront the complexities of cancer. The new center also intends to encourage more patients’ perspectives in FDA’s regulatory decision making, an idea that became a personal mission after his wife Mary died from ovarian cancer in November 2015.


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