As we have mentioned in a previous article, the 21st Century Cures Act (enacted December 13, 2016) gave companies 60 calendar days to make their expanded access policies for certain investigational drugs publicly available. That deadline—Saturday, 11 February 2017—arrives in a matter of days.
Section 3032 of the Cures Act sets out criteria for determining whether a company must publicly post an expanded access policy and lists five required elements of each policy, including procedures for the public to make expanded access requests to the company and the company's general criteria for evaluating and responding to such requests.
