edited by Douglas J. Pisano and David Mantus

Features:

• Provides a road map to the FDA and drug, biologic, and medical device development
• Offers current, real time information in a simple and concise format
• Contains a chapter highlighting the new drug application (NDA) process
• Discusses FDA inspection processes and enforcement options
• Includes contributions from experts at companies such as Millennium, Genzyme, leading CROs such PAREXEL, Biologics Consulting Group, and the FDA

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.

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, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics demystifies the inner workings of the FDA and allows you to understand how it operates with respect to product approval.

Contents

1. Overview of Drug Development and the FDA
   1. Brief History of Drug Laws and Regulations
   2. Regulatory Oversight of Pharmaceuticals
   3. New Drug Approval and Development
   4. Preclinical Investigation
   5. Investigational New Drug Application (INDA)
   6. Phase I
   7. Phase II
   8. Phase III
   9. New Drug Application (NDA)
   10. PDUFA/FDAMA Effects
   11. Biologics
   12. Orphan Drugs
   13. Abbreviated New Drug Applications (ANDA)
   14. Phase IV and Postmarketing Surveillance
   15. Over-The-Counter (OTC) Regulations
   16. Regulating Marketing
   17. Violations and Enforcement

2. Regulatory Strategy
   18. Introduction
   19. Overview of a Regulatory Strategy
   20. Regulatory Strategies for Different Phases of Product Development

3. What is an IND?
   21. What is an IND?
   22. Pre-IND Meeting
   23. The Content and Format of an IND Application
   24. Maintaining an IND: IND Amendments and Other Required Reports
   25. Other Types of INDs
   26. Promotion and Charging for Investigational Drugs
   27. More Information About INDs

4. Formatting, Assembling, and Submitting the New Drug Application (NDA)
   28. FDA Guidelines
   29. Assembling Applications for Submission
   30. NDA
   31. The NDA in CTD Format

5. Meeting with FDA
   32. Types of FDA Meetings
   33. FDA Expectations
   34. Preparing for FDA Meetings
   35. Conduct at FDA Meetings
   36. Avoiding the Pitfalls
   37. Specific Meeting Objectives

6. Biologics
   38. Definition of a Biologic Product
   39. The Center for Biologics Evaluation and Research (CBER)
   40. Preclinical Issues Unique to Biological Products
   41. The Biologics License Application (BLA)
   42. The Future of Biologics Regulation

7. FDA Medical Device Regulation
   43. Is It a Device?
   44. Medical Device Classification
   45. An Introduction to the Medical Device Approval Process
   46. Design Controls
   47. Medical Device Clinical Research
   48. The 510(k) Premarket Notification
   49. The Premarket Approval Application
   50. The Quality System Regulation (QSR)
   51. Postmarketing Issues

8. The Development of Orphan Drugs
   52. FDA Office of Orphan Products Development
   53. The Designation Process
   54. Tax Credits
   55. PDUFA and Orphan Products Development
   56. Orphan Product Grants Program
   57. Clinical Trial Design for Rare Disease Treatment
   58. Accomplishments

9. Good Clinical Practices
   59. How Research Was Done
   60. The Need for Global Standards in Research
   61. What are the GCPs? Regulations and Guidance
   62. GCP-Sponsor Obligations
   63. Sponsor Oversight of Clinical Studies
   64. Documentation/Reporting of Study Monitoring
   65. FDA's Oversight of Clinical Studies
   66. Sponsor's "Unbiased" Oversight of Clinical Studies
   67. GCP: A Complete Sponsor Effort
   68. Frequently Asked Questions
   69. Attachments
   70. Web Resources

10. Good Manufacturing Practices (GMPS) and Enforcement Actions
    71. Regulations
    72. Current Good Manufacturing Practices
    73. FDA Enforcement Actions
    74. Reporting Changes
    75. The Role of the Regulatory Affairs Professional in cGMPs
    76. Risk-Based GMP Approach

11. Electronic Submissions: A Guide for Electronic Regulatory Submissions to FDA
    77. Overview of Regulations
    78. History and Background
    79. FDA Submission Types
    80. Planning a Regulatory Submission
    81. The Electronic Submission (eSubmission) Process
    82. Electronic Submissions

12. The Practice of Regulatory Affairs
    83. What is "Regulatory Affairs"?
    84. Background and Training
    85. Attitude and Approach
    86. Information
    87. Documentation
    88. Submissions

13. A Primer of Drug/Device Law or What's the Law and How Do I Find It?
    89. What Is a Law?
    90. Who Makes Laws?
    91. What is the Difference Between A Federal Law and A State Law? Which One is More Important?
    92. Where Do I Find Laws?
    93. How Do I Find Current Laws?
    94. What is the Difference between the U.S. Code and the Public Laws? How are Laws Published?
    95. Publication
    96. Why Can't I Find Section 510(k) in the U.S. Code?
    97. Are There Any State Laws That Apply to Medical Products?
    98. Who Enforces Laws?
    99. What Is a Regulation?
    100. What Is the Difference between a Law and a Regulation?
    101. Which Is More Important - a Law or a Regulation?
    102. What Is the Difference Between the USC and the CFR?
    103. How Do I Find a Current Regulation?
    104. What Is a Guidance?
    105. What is a Search Engine and How Do I Use it?

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