Pharmaceutical Requirements and Implementation of the 21st Century Cures Act

FDAnews has compiled a list of the 21st Century Cures Act’s requirements and deadlines most relevant to the FDA and the pharmaceutical industry, including upcoming guidances, policies and public reports.

The law instructs the agency to produce draft and final guidances on several topics, including the use of real-world evidence and novel clinical trial designs — and mandates the creation of at least one new FDA institute, focused on a currently undetermined disease area, to coordinate product reviews and research across CDER, CBER and CDRH.

It also requires drugmakers to publically post contact information and policies regarding compassionate use requests, and to include specific labeling information if approved under a new limited population pathway.