By ALISON-BATEMAN HOUSE In April 2016, I published guidance, in the form of a mock case study, on how to access a drug before it has been approved by the FDAwhats known as pre-approval (or expanded or compassionate) access. In particular, the FDA rolled out a new, streamlined form for single-patient requests, and Congress passed the 21st Century Cures Act, which, among many other things, mandated that certain pharmaceutical companies provide public information about their pre-approval access policies. Last night, you saw a news story about a pharmaceutical company with a drug in development that, in theory, could minimize the impact of Zika on fetuses.

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