431 - Hello, in case of branded APS, are references older than 10 years not accepted? Thanks!



  • It is possible for an old reference to be questioned, but this is not necessarily the case. PAAB has rejected references which are less than 10 years old and PAAB has accepted references which are more than 10 years old. There is no single magical cut-off period. This is because it is NOT simply a matter of how long ago the reference was published. Rather, it is a matter of whether there are reasonable grounds to presume that the reference is still reflective of the present state of affairs. Passage of time is a factor in so far as circumstances which determine/influence the state of affairs change over time. For example: medical practice evolves, new products come to market, public policy shifts, health promotion practices change, the epidemiology of conditions change...etc.It is true that the more time elapses the more opportunity for factors to impact the applicability of the older data to today's reality; however, some issues are much more dynamic than others. In fact, there are very old references which still reflect (or likely reflect) the present state of affairs. There are also very recent publications which deal with topics which are so dynamic that they are already out of date (e.g. incidence of antibiotic resistance for an antibiotic).


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