Approval as a riskbenefit determination

Substantial evidence that a drug is effective for use is a necessary, but insufficient, condition for approval by a regulatory agency. A drug must also be found 'safe for use', and there must be sufficient information and clinical experience under the proposed conditions of use to draft product labelling that will allow a drug to be used prudently as recommended. Accordingly, approval determinations reflect a judgement that integrates many different and varied kinds of information, and is the determination of a review team that the expected benefits of the drug's use are sufficient to outweigh its known hazards. Moreover, the risks of a drug, even one that has been extensively studied prior to marketing, are invariably only incompletely characterized at the time of its initial marketing. (16,)

Breaking Bulimia

Breaking Bulimia

We have all been there: turning to the refrigerator if feeling lonely or bored or indulging in seconds or thirds if strained. But if you suffer from bulimia, the from time to time urge to overeat is more like an obsession.

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