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Legal Foundations of Adaptive Licensing
Author(s) -
Oye K,
Baird L G,
Chia A,
Hocking S,
Hutt P B,
Lee D,
Norwalk L,
Salvatore V
Publication year - 2013
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2013.95
Subject(s) - statute , reimbursement , agency (philosophy) , food and drug administration , inspector general , clinical pharmacology , drug approval , law , business , political science , public administration , pharmacology , medicine , drug , health care , accounting , sociology , social science , audit
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. Clinical Pharmacology & Therapeutics (2013); 94 3, 309–311. doi: 10.1038/clpt.2013.95