TagFDA

Reporting of side effects in RRMS trials

Most research is about investigating the known unknowns. In other words, investigators have a certain hypothesis, but also a range of plausable possibilities as outcomes. However, in some instances the outcome is unexpected – the unknown unknown. Rare side effects are an example of this, and not always evident in the initial randomized-placebo (dummy treatment) controlled clinical trials...

Are nutritional supplements a waste of money?

Do you take dietary supplements? If yes, are you prepared to review what you are taking and ask yourself if you need to spend the money taking something that is not supported by any evidence? In the US the Food and Drug Administration (FDA) has recently announced measures to regulate dietary supplements. The FDA Commissioner Scott Gottlieb said: “It’s clear that the US Food and Drug...

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