The move is an attempt by the US regulator to encourage sponsors to run paediatric studies – where it is appropriate – and solve the problem of new drugs, biologics, and medical devices coming to market with very little information on how they should be used in young people.
“Historically, children were not included in clinical trials because of a misperception that excluding them from research was in fact protecting them,” says the draft guidance, which is open for comment until 27 December.
