Using a unique reverse-engineering approach, dozens of leading experts with extensive experience in all disciplines of drug and biologic development show how careful planning and a sharp focus on the end-goals can be used to expedite even the most complex product development programs today! From the first preclinical testing to clinical trials to the NDA/BLA review, Expediting Drug and Biologics Development shows you how to use reverse-engineering techniques to drive and improve each aspect of a development program's design and implementation.

Expediting Drug & Biologics Development: A Strategic Approach

Science & Math

Linberg, Steven E.

Biological Sciences

Barnett Educational Services / Chi

New Drug Approval in the United States

Reference

Mathieu, Mark P.

Mathieu, Mark

Encyclopedias & Subject Guides

New Drug Approval in Japan

Russell, Keith

Bremer, William W.

Medical Books

New Drug Development: A Regulatory Overview

Mark P. Mathieu

Medicine

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

Mark Mathieu

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

Using a unique reverse-engineering approach, dozens of leading experts with extensive experience in all disciplines of drug and biologic development show how careful planning and a sharp focus on the end-goals can be used to expedite even the most complex product development programs today! From the first preclinical testing to clinical trials to the NDA/BLA review, Expediting Drug and Biologics Development shows you how to use reverse-engineering techniques to drive and improve each aspect of a development program's design and implementation. The new third edition of Expediting Drug and Biologics Development is not a summary of U.S. or international regulatory requirements. Rather, it is a real-world doer's guide to drug and biologics development. It provides dozens of templates, forms, and tools to assists those in the trenches of new drug and biologic development today. With this book, you will learn how to: * Apply the very latest and most advanced project management techniques directly to challenges presented by the drug development process. * Critically evaluate the needs of the package insert and marketing application up front, before getting deeply into clinical trials. * Leverage standardization to drive and expedite the entire development process, from the development of clinical trial protocols to the development of clinical data presentations. * Critically assess the needs of the final report before developing the clinical protocol. * Use draft case report forms (CRF) to dictate the content of the procedures section of the clinical protocol. * Constructively consider the methods for data analysis in developing the clinical protocol. In addition, Expediting Drug and Biologics Development 2006 will provide you with direct access to the expertise and recommendations of dozens of the most experienced and forward-thinking experts in the pharmaceutical and biotechnology industries today.

Expediting Drugs and Biologics Development: A Strategic Approach 2006

Steven E. Linberg

Good Clinical Practice: A Question and Answer Reference Guide 2006

Unknown, Author

Chemistry

Medical Device Development: Regulation and Law, 2nd Edition, is the must-have resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides the most comprehensive and updated analysis of US medical device and diagnostics development and approval requirements anywhere. This book also features in-depth analysis on how emerging developments and trends are reshaping medical device and combination product regulations in the US. The second edition of this popular and authoritative resource addresses the latest regulatory and legal developments that guide how medical devices are developed today: * The Medical Device User Fee and Modernization Act of 2002, including user fees, third party inspections, reprocessed single use devices, and the establishment of the Office of Combination Products. * The Food and Drug Administration Amendments Act of 2007, including unique device identifiers, ClinicalTrials.gov registration, pediatric device promotion, and postmarket surveillance and medical device reporting changes. * The current and future landscape of electronic 510(k) and PMA submissions. New chapters and features in the second edition include: * Medical Device Compliance and Postmarket Surveillance requirements. * Quality System Regulation, including management controls, design controls, risk analysis and corrective and preventive action, and other QSR provisions. * In Vitro Diagnostics, including IVD clinical studies, ASR regulation, LDTs, CLIA, and IUO/RUO requirements. * Combination Products and Product Jurisdiction, including a description of FDA s jurisdictional decision-making for single entity products, the establishment of the Office of Combination Products and its jurisdiction and processes, with a detailed discussion of the new definition of the primary mode of action. * A glossary and comprehensive index of terms and concepts.

Medical Device Development: Regulation and Law

Hartson

HOGAN

Kahan, Jonathan S.

Administration & Medicine Economics

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