"Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including: how the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements; how the CDER's efforts to integrate a culture of drug safety has affected the center's structure and its new drug review and approval processes; how CDER's much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDA's drug submission and review process; how the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions; and which drug development strategies are fulfilling their promise and offering optimal returns for industry, given the explosion of accelerated development/approval programs and pilot programs to speed the drug development and review process."--Publisher's description.
""Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including: how the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements; how the CDER's efforts to integrate a culture of drug safety has affected the center's structure and its new drug review and approval processes; how CDER's much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDA's drug submission and review process; how the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions; and which drug development strategies are fulfilling their promise and offering optimal returns for industry, given the explosion of accelerated development/approval programs and pilot programs to speed the drug development and review process."--Publisher's description."@en
This is a placeholder reference for a Organization entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Place entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Place entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
Essais cliniques comme sujet Norme États Unis d'Amérique.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
Législation produit chimique ou pharmaceutique États Unis d'Amérique.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.
This is a placeholder reference for a Topic entity, related to a WorldCat Entity. Over time, these references will be replaced with persistent URIs to VIAF, FAST, WorldCat, and other Linked Data resources.