FDA Regulatory Affairs
Crc Press Inc (Verlag)
978-1-58716-007-3 (ISBN)
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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.
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?
| Erscheint lt. Verlag | 23.12.2003 |
|---|---|
| Zusatzinfo | 29 Tables, black and white; 53 Illustrations, black and white |
| Sprache | englisch |
| Maße | 156 x 235 mm |
| Gewicht | 522 g |
| Themenwelt | Medizin / Pharmazie ► Pharmazie |
| Technik | |
| ISBN-10 | 1-58716-007-2 / 1587160072 |
| ISBN-13 | 978-1-58716-007-3 / 9781587160073 |
| Zustand | Neuware |
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