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Fundamentals of US Regulatory Affairs, Seventh Edition

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Fundamentals of US Regulatory Affairs, Seventh Edi

The essential reference for those working within the US regulatory environment. The comprehensive, yet concise text covers the current regulatory requirements for the US Food and Drug Administration (FDA) and other state and federal agencies.

The one-of-a-kind publication features the full range of established regulatory requirements across product lines and throughout the product lifecycle. Take advantage of the comprehensive reference matrix to get to the information you need more quickly.

» View the Table of Contents

Fundamentals of US Regulatory Affairs, Eighth Edition will be available in early July 2013.

Who should use this publication?

Fundamentals is designed to be a reference resource for regulatory professionals at all levels—from those new to the field or preparing for the US RAC exam, to senior management looking for a quick fact or information on a less-familiar product line.

Special Offer

Get the e-book version when you select the bundled option for $60 more. The e-book is compatible with any device that will read an .epub file, including iPads and most tablet readers

The Fundamentals of Regulatory Affairs series is available for a number of regions, including:

Copyright 2012, RAPS

Fundamentals of US Regulatory Affairs, Seventh Edition

Table of Contents

Section I: General Information
Chapter 1: History of FDA and Related Regulatory Agencies 1
Chapter 2: History of Food, Drug and Cosmetic Law 11
Chapter 3: Overview of Drug, Biologic and Device Regulatory Pathways 17
Chapter 4: FDA Communications and Meetings 45
Chapter 5: Preparing for Key FDA Meetings and Advisory Committee Meetings 53
Chapter 6: Good Laboratory Practice Regulations 63
Chapter 7: Clinical Trials: GCPs, Regulations and Compliance 73
Chapter 8: Current Good Manufacturing Practice and Quality System Design 91

Section II: Drugs
Chapter 9: Prescription Drug Submissions 105
Chapter 10: Postapproval Prescription Drug Submissions and Compliance 119
Chapter 11: Generic Drug Submissions 133
Chapter 12: Patents and Exclusivity 157
Chapter 13: Over-the-Counter Drug Products 169
Chapter 14: Prescription Drug Labeling, Advertising and Promotion 177

Section III: Medical Devices
Chapter 15: Medical Device Submissions 189
Chapter 16: Medical Device Compliance and Postmarketing Activities 203
Chapter 17: Advertising, Promotion and Labeling for Medical Devices and IVDs 225
Chapter 18: In Vitro Diagnostics Submissions and Compliance 233

Section IV: Biologics
Chapter 19: Biologics Submissions 239
Chapter 20: Biologics Compliance 255
Chapter 21: Biologics Labeling, Advertising and Promotion 265

Section V: Other Product Classifications
Chapter 22: Combination Products 275
Chapter 23: Regulation of Products for Small Patient Populations 285
Chapter 24: Blood and Blood Products 293
Chapter 25: Human Cell and Tissue Products 301
Chapter 26: Regulations Pertaining to Pediatrics 309
Chapter 27: Dietary Supplements and Homeopathic Products 317
Chapter 28: Cosmetics 337
Chapter 29: Veterinary Products 345
Chapter 30: Food Products 355

Section VI: Inspection and Enforcement
Chapter 31: FDA Inspection and Enforcement 369
Chapter 32: Healthcare Fraud and Abuse Compliance 379

Section VII: Resources
Chapter 33: Regulation Information Resources in Review 387

Appendices
Comparative Matrix of Regulations Across Product Lines 405
Glossary of Terms 433
Index 451

Figures
Figure 1-1 Food and Drug Administration Organizational Chart 3
Figure 3-1 CTD Organization 29
Figure 3-2 Decision Tree for Drug and Device Development and Approval for Situations That Require FDA Premarket Review 35
Figure 4-1 Timeline for Key Application Meetings (NDA and BLA) 47
Figure 5-1 Major Milestone Timeline 56
Figure 5-2 Sample Project Management Chart 57
Figure 8-1 Process Model for Meeting GMP Requirements 104
Figure 9-1 CTD Triangle 113
Figure 9-2 Primary NDA Review Stage 116
Figure 11-1 OGD ANDA Backlog 135
Figure 11-2 Median ANDA Approval Times 136
Figure 11-3 FDA’s ANDA Approval Process 137
Figure 13-1 Example of an OTC Drug Facts Label 173
Figure 16-1 Quality System Elements 210
Figure 16-2 Relationship of Medical Device Records 211
Figure 16-3 Total Product Lifecycle 219
Figure 25-1 Form FDA 3356 304
Figure 27-1 Sample Supplement Facts Boxes 321

Tables
Table 1-1 CDER vs. CBER Product Oversight Responsibilities 5
Table 1-2 Selected Primary FDA Centers/Offices Involved in Sponsor Interface During the Development and Approval of Drugs and Devices 7
Table 2-1 Other Laws, Regulations and Guidelines 15
Table 3-1 21 CFR Parts Most Relevant to Drug and Device Development 20
Table 3-2 Key Questions to be Addressed in a Drug Development Program 25
Table 3-3 IND Safety Reports Reporting Timeframes 31
Table 3-4 Summary of Device Classification System 38
Table 4-1 Description of FDA Product Application Meetings and Timing 48
Table 6-1 21 CFR 58 66
Table 7-1 Common Rule vs. Privacy Rule 76
Table 7-2 Clinical Trial Regulations Comparison Between Investigational New Drugs and Investigational Devices 78
Table 7-3 Clinical Trial Regulations Applicable to Investigational New Drugs and Investigational Devices 79
Table 7-4 List of Clinical Trial State Legislation and Insurance Legislation 80
Table 10-1 Postapproval CMC Changes 123
Table 12-1 180-Day Exclusivity Forfeiture Snapshot 159
Table 12-2 Differences Between Applications Submitted and Approved Under FD&C Act Section 505  160
Table 13-1 NDA vs. OTC Monograph 170
Table 13-2 OTC Monograph Therapeutic Category Subtopics Evaluated as Part of the OTC Review Process 171
Table 14-1 PLR Format, Associated Regulations and Guidance Documents 180
Table 15-1 Abbreviated IDE Requirements, per 21 CFR 812.2(b) 193
Table 16-1 Domestic Establishment Registration and Listing Requirements 207
Table 16-2 Foreign Establishment Registration and Listing Requirements 208
Table 16-3 Registration and Listing Timelines 209
Table 16-4 Summary of Reporting Requirements for Manufacturers 212
Table 16-5 Summary of Reporting Requirements for User Facilities and Importers 213
Table 19-1 History of Biologics Regulation 242
Table 19-2 Key CMC Guidance for Development of Biological Products 247
Table 22-1 Unique Proposed Postmarket Safety Reporting Provisions for Combination Products 281
Table 25-1 21 CFR 1271 at a Glance: Effective 25 May 2005 303
Table 25-2 FDA Regulation of Minimally Manipulated Cord Blood Products 307
Table 26-1 Definition of Pediatric Subpopulations 311
Table 33-1 Publisher Resources 396
Table 33-2 Commercial and Government Databases 400
Table 33-3 Agencies Associated With Healthcare Product Regulation 402

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