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These standardised documents provide meticulously curated and scientifically approved information. The responsibility of printing paper leaflets is currently a key regulatory obligation for pharmaceuticalcompanies. They detail the medication’s intended use, proper administration, potential side effects and precautions.
2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.
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