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,)

Break Free From Passive Aggression

Break Free From Passive Aggression

This guide is meant to be of use for anyone who is keen on developing a better understanding of PAB, to help/support concerned people to discover various methods for helping others, also, to serve passive aggressive people as a tool for self-help.

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