As health care across the globe shifts to a more patient-focused model, one of the challenges is getting patients to be more accountable for their own health.
Reports of a myeloma patient and her family being kicked off an airplane this week highlight some of the problems with turning patient-expressed needs into science-based assessments that can be used to measure endpoints in clinical trials for new drugs and devices.
Responding to its eighth FDA warning letter in seven years, Hospira Inc. has committed to working with a third-party consultant to conduct a comprehensive assessment of its manufacturing, laboratory and quality operations.
As health care across the globe shifts to a more patient-focused model, one of the challenges is getting patients to be more accountable for their own health.
The old adage "you get what you pay for" may not hold true for new cancer drugs. A study of cancer drugs approved by the FDA between 2009-2013 shows little correlation between the efficacy of a drug and its price tag.
The FDA is tweaking its plans to study how best to present price comparisons in physician and direct-to-consumer (DTC) ads without implying that two prescription drugs are interchangeable. While the research will focus on diabetes medications, the results could impact how drugmakers market biosimilars in the U.S.
It's one thing to listen to patients and understand what's important to them. But it's much more difficult to translate the patient voice into a science-based tool that can be used to measure meaningful risks and benefits of a drug in clinical trials.
