Avalanche of New Cancer "Products" Will Confront the FDA

Cancer diagnosis and treatment is booming (see: What is cancer immunotherapy?) and the FDA is adapting to these changes with an organizational change. A recent article discussed a recent major organizational shift at the agency (see: Top Officials Aim To Reshape The FDA To Prepare For 'Avalanche' Of Cancer Products). Below is an excerpt from the article: For 20 years, Richard Pazdur has run the office of the Food and Drug Administration charged with evaluating new cancer drugs, guiding the pharmaceutical industry as the business of oncology went from a relative backwater to the main event....[A]s part of the $1 billion National Cancer Moonshot effort being run by Vice President Joseph Biden, Pazdur was elevated to a new role: running a new Oncology Center of Excellence that will coordinate all of the FDA’s clinical efforts in cancer. Cancer medicines now account for 40% of the drugs under development, but the current revolution–that’s the word most doctors use–going on in cancer care doesn’t just involve drugs. Previously, Pazdur had authority over the pills and antibodies developed by companies like Roche, Merck and Bristol-Myers Squibb. But diagnostic tests, from firms like Illumina and Foundation Medicine, are likely to be just as important. And now companies like Novartis , Juno Therapeutics and Kite Pharmaceuticals are developing genetically engineered cells that hunt down and kill cancer–products that would be reviewed by yet another FDA ...
Source: Lab Soft News - Category: Laboratory Medicine Authors: Source Type: blogs