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(1)审批法规指南: a searchable,
topical guide to CDER guidance documents.
(2)药物专利延期和新专利:This
file lists new
(6/20/2003) and cumulative
(2/10/2003) drug
patent and exclusivity information.
(3)药理和毒理审批法规:
This
complete list of guidances includes pharmacokinetics,
toxicokinetics, single and repeat dose toxicity, genotoxicity,
carcinogenicity, reproductive toxicity, impurities,
and others, including published drafts.
(4)
NIH
基金申请技巧:
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