New Drug Approval in the United States

Reference

Mathieu, Mark P.

Mathieu, Mark

Encyclopedias & Subject Guides

Barnett Educational Services / Chi

This publication is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era. Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. Written by CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products.

Biologics Development: A Regulatory Overview

Science & Math

Mark P. Mathieu

Mark Mathieu

Biological Sciences

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. * 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. Find out why New Drug Development is pharma/biotech's go-to resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDA's drug development approval processes.

New Drug Development: A Regulatory Overview (NEW DRUG DEVELOPMENT ( MATHIEU))

Evans, Anne G.

Parexel International Corporation

Chemistry

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Books by Mathieu, Mark P.