CiNii Books - FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics

Since the enactment of the first drug law in 1848, the legislation surrounding drug development has evolved into a maze of regulations that can be hard to navigate. Not only are existing regulations constantly reviewed and updated, the increasingly rapid rate of development in the pharmaceuticals field creates new issues that need to be addressed by new legislation. Written in plain language without confusing jargon or legalese, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics provides a roadmap to the myriad and sometimes confusing regulations that govern this constantly changing field. The book examines the pertinent aspects of the Federal Food, Drug, and Cosmetic Act as they apply to human drug and device development, research, manufacturing, and marketing. It focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and the corresponding documentation requirements. Although there are a number of references on these topics, this book is unique in that it is written in a general, easy to read prose style. It presents information drawn from a wide range of resources in a single, easy to use format. FDA approval can be a lengthy and expensive process. In order for a pharmaceutical manufacturer to place a product on the market for human use, a multiphase procedure must be followed. Providing a reference for students, professionals, and especially those who are charged with the day-to-day tasks of assuring regulatory compliance under FDA guidelines, this book demystifies the inner workings of the FDA and allows you to understand how it operates with respect to product approval.

Table of Contents

OVERVIEW OF DRUG DEVELOPMENT AND THE FDA, D.J. Pisano Brief History of Drug Laws and Regulations Regulatory Oversight of Pharmaceuticals New Drug Approval and Development Preclinical Investigation Investigational New Drug Application (INDA) Phase I Phase II Phase III New Drug Application (NDA) PDUFA/FDAMA Effects Biologics Orphan Drugs Abbreviated New Drug Applications (ANDA) Phase IV and Postmarketing Surveillance Over-The-Counter (OTC) Regulations Regulating Marketing Violations and Enforcement Summary REGULATORY STRATEGY, J. Dombroski Introduction Overview of a Regulatory Strategy Regulatory Strategies for Different Phases of Product Development Conclusions WHAT IS AN IND? R. Pietrusko and T. Class What is an IND? Pre-IND Meeting The Content and Format of an IND Application Maintaining an IND: IND Amendments and Other Required Reports Other Types of INDs Promotion and Charging for Investigational Drugs More Information About INDs FORMATTING, ASSEMBLING, AND SUBMITTING THE NEW DRUG APPLICATION (NDA), D. Pizzi and J.C. Rae FDA Guidelines Assembling Applications for Submission NDA The NDA in CTD Format MEETING WITH THE FDA, A. Grignolo Types of FDA Meetings FDA Expectations Preparing for FDA Meetings Conduct at FDA Meetings Avoiding the Pitfalls Specific Meeting Objectives Conclusion BIOLOGICS, J. Kenimer and J.J. Jessop Definition of a Biologic Product The Center for Biologics Evaluation and Research (CBER) Preclinical Issues Unique to Biological Products The Biologics License Application (BLA) The Future of Biologics Regulation FDA MEDICAL DEVICE REGULATION, B. Sall Introduction Is It a Device? Medical Device Classification An Introduction to the Medical Device Approval Process Design Controls Medical Device Clinical Research The 510(k) Premarket Notification The Premarket Approval Application The Quality System Regulation (QSR) Postmarketing Issues THE DEVELOPMENT OF ORPHAN DRUGS, M.E. Haffner Introduction FDA Office of Orphan Products Development The Designation Process Tax Credits PDUFA and Orphan Products Development Orphan Product Grants Program Clinical Trial Design for Rare Disease Treatment Accomplishments GOOD CLINICAL PRACTICES, R. Buckley Introduction How Research Was Done The Need for Global Standards in Research What are the GCPs? Regulations and Guidance GCP-Sponsor Obligations Sponsor Oversight of Clinical Studies Documentation/Reporting of Study Monitoring FDA's Oversight of Clinical Studies Sponsor's "Unbiased" Oversight of Clinical Studies GCP: A Complete Sponsor Effort Frequently Asked Questions Attachments Web Resources GOOD MANUFACTURING PRACTICES (GMPS) AND ENFORCEMENT ACTIONS, C. Hay and F. Kaltovich Introduction Regulations Current Good Manufacturing Practices FDA Enforcement Actions Reporting Changes The Role of the Regulatory Affairs Professional in cGMPs Risk-Based GMP Approach Summary ELECTRONIC SUBMISSIONS: A GUIDE FOR ELECTRONIC REGULATORY SUBMISSIONS TO FDA, S. Kumar and V. Ghahraman Introduction Overview of Regulations History and Background FDA Submission Types Planning a Regulatory Submission The Electronic Submission (eSubmission) Process Electronic Submissions Summary THE PRACTICE OF REGULATORY AFFAIRS, D. Mantus Introduction What is "Regulatory Affairs"? Background and Training Attitude and Approach Information Documentation Submissions Conclusions A PRIMER OF DRUG/DEVICE LAW OR WHAT'S THE LAW AND HOW DO I FIND IT? J. Babiarz What Is a Law? Who Makes Laws? What is the Difference Between A Federal Law and A State Law? Which One is More Important? Where Do I Find Laws? How Do I Find Current Laws? What is the Difference between the U.S. Code and the Public Laws? How are Laws Published? Publication Why Can't I Find Section 510(k) in the U.S. Code? Are There Any State Laws That Apply to Medical Products? Who Enforces Laws? What Is a Regulation? What Is the Difference between a Law and a Regulation? Which Is More Important - a Law or a Regulation? What Is the Difference Between the USC and the CFR? How Do I Find a Current Regulation? What Is a Guidance? What is a Search Engine and How Do I Use it?

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FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics

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