email envelope and APS are technically reviewed separately so no claims can be made without full balance.
Study and product also can't be mentioned together
ie. Nothing can 'trigger' a need for fair balance
Fair balance is meant to signify the end of a piece with exception of references and footnotes
FB must be >=75% of size of copy
Any clinical claim must have high level fair balance (unless its a journal ad but has to lead to high level)
all claims must have an attitude of caution and need to be inclusive of all incidence
Cannot cherry pick data
important to have "clinical significance has not ben established" for non clinical claims
All claims have to be applied to the product or otherwise specified
claims cant be superlative unless they can be supported
All visuals must not be implicative of other claims
Need medreg letters to support non-clinical claims
have to be listed in the past tense, and not listed as instantaneous
comparators have to be specific and not overly broad
Graphs: can differentiate medians - not statistically revelant
Claims made must be based on data that has been statistically analyzed
All graphs must contain a claim of adapted from....