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But the FSA launched an investigation into the labelling claim after it emerged that Dasani is sourced from mains water.
"We are confident that all of our sun care products, including Boots Soltan Protect & Moisturise Lotion SPF30, meet the SPF labelling claim and customers can rely on them to provide the level of protection expected".
To discuss issues in the design of a measurement strategy related to the use of patient-reported outcomes (PROs) in support of a labelling claim.
QoL has never been approved in a labelling claim because of its vagueness.
The use of these data to support a labelling claim requires the use of a rigorous methodology, based on valid and reliable instruments, used when appropriate.
However, acquiring the meaningfulness of PRO measures transcends beyond a concept of the MID and we advocate that dichotomizing the scores of patient-reported outcome measures facilitate interpretability of clinical trial results for those who need to understand trial results after a labelling claim has been granted.
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Historically, PROs have had a limited role in oncology labelling claims.
Boots said it was confident that all its sun care products met the SPF labelling claims.
It is necessary that responsiveness and MID be well documented in order to use PROs in labelling claims.
Recently, the FDA and EMA have published guidance for industry on how to utilize PROs in applications for drug labelling claims.
This work aimed to evaluate the content validity of the asthma symptom diary (ASD) for use as an efficacy endpoint in asthma clinical trials to support labelling claims.
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