Role Of The Us Food And Drug Administration In Cancer Drug Development
PRINCIPLES OF ANTICANCER DRUG DEVELOPMENT(2011)
摘要
The US Food and Drug Administration (FDA) oversees the development of agents to diagnose, cure, mitigate, treat, or prevent
cancer. The FDA’s mission statement is “The FDA is responsible for protecting the public health by assuring the safety, efficacy,
and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and
products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations
that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based
information they need to use medicines and foods to improve their health” [1]. The FDA accomplishes its mission through meetings
with individual investigators and sponsors, review of investigational new drug (IND) and new drug applications (NDA), facilities
inspections, approval of marketing and licensing applications, and the administration of grant programs.
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