[Martin Harper]

Reply To: EAP from Open label studies

Hi Amy,

Gretchen is quite right with her reply but I would also add that sometimes EAPs are used to allow patients access to medicines where the there is no intention of seeking approval or reimbursement in a territory. To your other point, there are a multitude of names for these programs – Early Access / Expanded Access / Managed Access and they seem to be inter changeable but broadly all mean the same thing.