Children should not be given medicines that have not been evaluated adequately for use in that age group. There is a responsibility, shared by applicants and the appropriate authorities, to ensure that children have timely access to safe and effective medicines that have accurate, scientifically justified prescribing information. Applicants are encouraged to investigate the safety and efficacy of a product in children, if it is likely to be of therapeutic benefit in this age-group, and to develop suitable formulation, even if use is likely to be small.

However important a clinical trial may be to prove or disprove the value of a treatment, individual members of one or both of the groups—subject or control—can suffer injury as a result of inclusion in the trial, even if the whole community benefits. As with adults who participate in clinical trials and who understand the issues involved in giving their informed consent, consent...

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