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Catalyzing the critical path initiative: FDA's progress in drug development activities
Author(s) -
Parekh A,
BuckmanGarner S,
McCune S,
ONeill R,
Geanacopoulos M,
Amur S,
Clingman C,
Barratt R,
Rocca M,
Hills I,
Woodcock J
Publication year - 2015
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 - 10.1002/cpt.42
Subject(s) - leverage (statistics) , drug development , intellectual property , food and drug administration , business , key (lock) , regulatory science , public relations , drug , medicine , political science , computer science , pharmacology , risk analysis (engineering) , computer security , pathology , machine learning , law
The US Food and Drug Administration (FDA) has directed considerable effort towards modernizing its regulatory processes over the past decade to address the challenges in the drug development sector. Through partnerships and input from stakeholders, multiple initiatives are under way, many projects have been launched, several have resulted in tangible results, and many are ongoing and under discussion. We are learning that collaborative efforts can better inform and leverage existing knowledge, that the challenges of data sharing and intellectual property can be overcome, and that there is wide interest in partnering to address key public health regulatory science issues. It is crucial that we continue to build on these initial efforts to facilitate drug development.