TagFDA

The secret to drug approval

Each generation is built on trends. Different in it’s uniqueness, like a manifesto set apart from the one before. Popular trends only need to be mentioned once or twice before the herd mentality takes over. Like fashion, cars and the financial world, the scientific world is also susceptible to the whims of trends. So here is a piece of research announcing how trends have influenced FDA (US...

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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