Real-World Evidence, Digital Health, Insurance Coverage Reforms On Cures 2.0 Agenda
All three areas need work following enactment of the original 21st Century Cures Act, authors Fred Upton and Diana DeGette write in vision statement.
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Cures 2.0 May Get Fast Tracked Due To COVID-19
Follow-up bill to the 21st Century Cures Act looks to be more focused on reimbursement and delivery than the 2016 law, which centered on speeding drug development and approval. The bill's architects are working to get some of their provisions, including those around antibiotics, attached to the next COVID-19 relief legislation.
Expanded Access Advocates Seek Reimbursement Mandate, Manufacturer Incentives From Congress
Next round of biomedical innovation legislation provides opportunity to require insurance reimbursement of investigational drugs and related medical services, as well as new incentives for small biotech companies to offer expanded access programs, stakeholders say.
Complex Generic Approval Delays Getting Congressional Attention
US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.