The US Food and Drug Administration (FDA) in August proposed a new guideline asking the sponsors of clinical trials to submit annual development safety update reports (DSURs). The guideline, titled “E2F Development Safety Update Report,” is in draft form and describes the format, content, and timing of a DSUR.
By Mary Gabb ( mary.gabb@rxcomms.com ) A negative result is defined as one that shows evidence of absent (or no) effect of an intervention; it is not due to absence…
By Ruth Whittington (ruth.whittington@rxcomms.com) With the NHS in the UK nearing its 60th birthday, there’s been considerable talk about whether the system should be put into retirement. At the recent…
By David Woods (david.woods@rxcomms.com) Whether it’s because of a shortage of primary care physicians, impatience at the length of time it takes to see one, or simply increasing costs, the…
By John F P Bridges While outcomes for any given treatment differ significantly among patients, national healthcare systems continue to take a top down population perspective in reviewing not only…
By Ruth Whittington (ruth.whittington@rxcomms.com) Many of us in health economics and outcomes research look at Canada as one of the leaders in the field; along with Australia , Canada was…
By Mary Gabb (mary.gabb@rxcomms.com) Nowadays, healthcare is hotly debated, and not just for US presidential candidates. Virtually every western country is now grappling with the challenge of how to pay…
By Ruth Whittington (ruth.whittington@rxcomms.com) The World Healthcare Congress, held March 10 – 13 in Berlin, always provides interesting insights on the ways governments, clinicians, and healthcare providers perceive healthcare delivery.…
By David Woods (david.woods@rxcomms.com) The pharmaceutical industry is too often blamed for the stratospheric costs of healthcare — particularly in the United States. Yet, according to a series of surveys…
By David Woods (david.woods@rxcomms.com) There has been much written lately about the perceived failings of the FDA. The Wall Street Journal claims that “the place is a mess,” and a…
