Related Experiment Videos
Legal foundations of adaptive licensing
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA. oye@mit.edu
Abstract:
In April 2012, MIT's Center for Biomedical Innovation and the European Medicines Agency (EMA) cosponsored a workshop on legal foundations of adaptive pharmaceuticals licensing. Past and present attorneys from the US Food and Drug Administration (FDA), the EMA, and Health Sciences Agency Singapore (HSA) found that existing statutes provided authority for adaptive licensing (AL). By contrast, an attorney from Health Canada identified gaps in authority. Reimbursement during initial phases of adaptive approaches to licensing was deemed consistent with existing statutes in all jurisdictions.
Related Concept Videos
Legal Guidelines for Documentation
Drug Control Governance: Regulatory Bodies and Their Impact
Sources of Law
Constitutional law is foundational, deriving from federal and state constitutions, and...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Global Regulatory Systems
Scientific Laws and Theories