FDA's Class II 510(k) clearance process for medium-risk devices—a category that includes the power morcellator—is inadequate, because it does not focus on risk assessment, according to Bill Vodra, a former associate chief counsel for drugs at FDA.
Lilly Oncology has launched a novel value assessment tool that aggregates 40 years of oncology data to measure progress and identify unmet needs in cancer treatments.
The Cancer Letter invited Richard Wender, chief cancer control officer of the American Cancer Society, to describe the rationale for the society’s new guideline for breast cancer screening.
After a decade of near-absence from the US market, the AstraZeneca drug Iressa (gefitinib) is back.
Here is what Hagop Kantarjian has learned over the past two years of his campaign to lower the prices of cancer drugs:People would rather avoid disputing you head-on.
The NCI-MATCH phase II study is intended to allow the institute and its clinical trials groups catapult to the premier role in cancer research.
A year ago, Fox Chase Cancer Center lost money: $17 million. In 2015, the losses have stopped, and an $8 million operating profit is projected.
The Cancer Letter invited C. K. Gunsalus, an expert on scientific misconduct, to discuss the settlement of the lawsuits against Duke.
So tell me about MED-C.
Dane Dickson would like to change the U.S. system for validation and coverage of molecular tests, thereby opening the road to development of complex tests and comprehensive genomic assays.
