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Regulatory Writing: An Overview (Hardcover)
- Συγγραφείς: By Various Authors
- ISBN: 9780997769760
- Εκδότης: RAPS
- Σελίδες: 234
- Έτος Έκδοσης: 2017
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Regulatory documentation is difficult to do well. A complex field of endeavor, regulatory writing requires knowledge about research, legal requirements, guidance for industry and the basic ethics of drug, vaccine, biologic and device development. Most conceptualizations of regulatory writing limit themselves to full-time experts in medical or clinical documentation. However, nonclinical and CMC writing also are important specialization areas, even though these frequently are learned as adjuncts to regulatory or research professions. This volume is only a starting point, intended to help set the stage for effective writing, using guidelines to aid in the construction of helpful, complete and concise documentation.
Contents
Section 1: General Considerations for Regulatory Writing
Chapter 1:
An Overview of Medical and Regulatory Writing .........................................................................................1
By Danny A. Benau, MSOD, PhD
Chapter 2:
Good Documentation Practices .................................................................................................................11
By Joanne Rupprecht, Esq., RAC (US, Global)
Chapter 3:
General Considerations for Quality Regulatory Writing .............................................................................21
By E. Mitchell Seymour, PhD, RAC (US)
Chapter 4:
Guidance Documents: Beyond the Code of Federal Regulations ................................................................27
By Lisa DeTora, Robin Martin, Jenny Boyar and Jenny Grodberg
Chapter 5:
Medical Device Submission Considerations Beyond the US, Canada and EU ............................................41
By Robin Martin, MBA, RAC
Chapter 6:
Developing SOPs, Planning and Strategy Documents ................................................................................45
By Mariam Aslam
Chapter 7:
Future Directions for Regulatory Writing ..................................................................................................55
By Steve Carr and Helle Gawrylewski
Section 2: Clinical Study Documents
Chapter 8:
Clinical Protocols .......................................................................................................................................59
By Sharanya Ramasubramanian
Chapter 9:
Informed Consent Form Preparation The Whys, Whats, Whos, Wheres, Whens and Hows ......................65
By Jenny Grodberg, PhD, RAC (US)
Chapter 10:
Data Analysis Plans ....................................................................................................................................71
By Lisa DeTora
Chapter 11:
Clinical Study Reports ...............................................................................................................................79
By Brooke Diorio, John Ellison, Helle-Mai Gawrylewski, Anna Mendlin and Bertil Wagner
vi
Section 3: Integrated and Interdisciplinary Documentation
Chapter 12:
Integrated CMC Documentation ..............................................................................................................89
By Mariam Aslam
Chapter 13:
Integrated Nonclinical Documentation ......................................................................................................93
By Lisa DeTora
Chapter 14:
Integrated Clinical Documentation ..........................................................................................................103
By Lisa DeTora and Dan Benau, MSOD, PhD
Chapter 15:
Investigator’s Brochure .............................................................................................................................117
By Tina O’Brien, MS, RAC (US)
Chapter 16:
Labeling ...................................................................................................................................................121
By Tina O’Brien, MS, RAC (US)
Chapter 17:
Background Packages ...............................................................................................................................127
By Jocelyn Jennings, MS, RAC
Chapter 18:
Responses to Questions or Requests for Information ...............................................................................137
Nathalie Innocent, MS, RAC
Chapter 19:
Interdisciplinary Document, Dossier Maintenance ..................................................................................143
By Evelyn De La Vega
Section 4: Special Topics
Chapter 20:
Value Dossiers ..........................................................................................................................................149
By E. Mitchell Seymour, PhD, RAC and Kayla Ambroziak, PharmD
Chapter 21:
Vaccines and Biologics .............................................................................................................................153
By Lisa DeTora
Chapter 22:
Biosimilars: Special Considerations ..........................................................................................................165
By Monica Ramchandani, MS, PhD
Chapter 23:
Combination Product Design and Development .....................................................................................173
By Jiyang Shen
Chapter 24:
Rare Diseases—Special Considerations ....................................................................................................181
By Beth Silverstein, MS, RAC
Chapter 25:
Pediatric Investigational Plan (PIP) ..........................................................................................................191
By Jocelyn Jennings, MS, RAC
Chapter 26:
Accelerated Filings ...................................................................................................................................197
By Joanne Rupprecht, JD, RAC (US)
Chapter 27:
Publications .............................................................................................................................................203
Eileen M. Girten, MS
Chapter 28:
Literature Reviews ....................................................................................................................................209
By Michelle Carey, PhD
Regulatory Writing: An Overview
vii
Index................................................................................................................................................................215
Figures
Figure 6-1.
Example Template Guide to Preparing Planning and Strategy Document for Regulatory Submission............47
Figure 6-2.
Example SOP Template .............................................................................................................................50
Figure 6-3.
Example Template Flow Diagram ..............................................................................................................51
Figure 6-4.
Example Template of Work Instruction ......................................................................................................52
Figure 11-1.
Flowchart for Developing CSRs .................................................................................................................82
Figure 16-1.
Labeling Examples ...................................................................................................................................122
Figure 18-1.
Example of Agency Deficiency Communication ......................................................................................141
Figure 22-1.
Stepwise Process for Biosimilarity Demonstration ....................................................................................166
Tables
Table 1-1.
Medical Writer Definitions ..........................................................................................................................3
Table 1-2.
Summary of the Prescription Drug User Fee Act (PDUFA) and its Reauthorizations...................................7
Table 4-1.
FDA Guidances for Vaccines and Related Biological Productsa ..................................................................29
Table 4-2.
Overview of Center for Drug Evaluation and Research Guidance for Regulatory Writersa.........................29
Table 4-3
Recently Published FDA Guidance for Regulatory Writersa ......................................................................30
Table 4-4.
Regulatory Requirements for Medical Devices ...........................................................................................30
Table 4-5.
Overview of ICH Quality Guidelinesa .......................................................................................................32
Table 4-6.
Overview of ICH Safety Guidelinesa .........................................................................................................33
Table 4-7.
Overview of ICH Efficacy Guidelinesa ......................................................................................................34
Table 4-8.
Overview of ICH Multidisciplinary Guidelinesa ........................................................................................36
Table 8-1.
Protocol Outline ........................................................................................................................................62
Table 9-1.
Selected Historical Events in Human Experimentation ..............................................................................66
Table 9-2.
Essential Informed Consent Form Elements ..............................................................................................67
Table 9-3.
Additional Informed Consent Form Elements ...........................................................................................68
Table 9-4.
Examples of Lay Language .........................................................................................................................69
Table 10-1.
Guidelines Specifically Referenced in ICH Statistical Principles for Clinical Trials E9................................73
Table 11-1.
Guidance Documents for CSRs .................................................................................................................80
Table 11-2.
Common Terminology for CSRs ...............................................................................................................81
Table 12-1.
Example Template of Section 3.2.P.3 Manufacture and 3.2.P.3.1 Manufacturer(s)* ....................................90
Table 13-1.
US FDA Nonclinical Testing Guidance Documentsa .................................................................................94
Table 13-2.
Content Areas of the Three Nonclinical Written Summaries .....................................................................98
Table 14-1.
Documents That May Contain an Integrated Discussion of Clinical Data ...............................................105
Table 14-2.
Clinical Overview Goals ..........................................................................................................................106
Table 14-3.
Clinical Overview Text Sections With Brief Explanationsa .......................................................................108
Table 14-4.
Summary of New Guidance on Clinical Overview Section 2.5.6 Benefit-Risk Conclusions
(Text Sections) .........................................................................................................................................109
Table 14-5.
Clinical Summary Text Subsectionsa ........................................................................................................110
Table 14-6.
ICH M4E Table Templates for Clinical Summary Subsectionsa ...............................................................111
Table 15-1.
Investigator’s Brochure Contents Specified in ICH E6, Section 7 .............................................................118
Table 16-1.
User Profile Examples .............................................................................................................................123
Table 16-2.
Common Labeling Elements ....................................................................................................................124
Table 16-3.
Labeling Risk Category Statements ..........................................................................................................125
Table 17-1.
FDA Meeting Types and Deadlines ..........................................................................................................128
Table 17-2.
Tips for Formulating Questions ...............................................................................................................129
Table 17-3.
Sponsor/Applicant-Areas That May Lead to Questions ............................................................................131
Table 17-4.
510(k) Submission Questions ..................................................................................................................133
Table 17-5.
PMA Submission Questions ....................................................................................................................134
viii
Table 19-1.
IDE Annual Report Contents ..................................................................................................................146
Table 19-2.
PMA Annual Report Contents.................................................................................................................146
Table 19-3.
IND Annual Report Contents .................................................................................................................146
Table 19-4.
ANDA/NDA Annual Report Contents ....................................................................................................146
Table 20-1.
AMCP Format .........................................................................................................................................150
Table 20-2.
Comparison of AMCP Dossier and International HTA ...........................................................................150
Table 20-3.
Team Members and Their Responsibilities ...............................................................................................151
Table 21-1.
Some Current US Biological Produce Definitions ....................................................................................154
Table 21-2.
European Medicines Agency (EMA) Biologics Definitions .......................................................................157
Table 21-3.
Division of Products Between CDER and CBER Under the 1991 Intercenter Agreementa .....................159
Table 21-4.
Division of Therapeutic Biological Products in CDER and Those Remaining in CBER
as of 30 June 2003a,b ...............................................................................................................................162
Table 22-1.
Differences in Regulatory Requirements for Reference Products, Generics and Biosimilars......................170
Table 24-1.
Available Resources ..................................................................................................................................188
Table 25-1.
Pediatric Population .................................................................................................................................192
Table 25.2.
PIP Submission Process ............................................................................................................................194
Table 27-1.
Common Publication Deliverables ...........................................................................................................204
Table 27-2.
Differences Between Regulatory and Publications Writing .......................................................................204
Table 27-3.
Transparency Initiatives Affecting Publications Writing ............................................................................206
Table 28-1.
Narrative Versus Systematic Reviews ........................................................................................................210
Table 28-2.
Examples of Electronic Information Sources ............................................................................................211
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