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From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic 64
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Do statins reduce mortality in older people? Findings from a longitudinal study using primary care records

BMJ

This is because clinical trials are expensive to carry out and therefore tend to be of relatively short duration, with statins trials having on average two to five years of treatment exposure. In clinical practice, patients are not fixed on a certain treatment regime and can start and stop at any time.