Regulatory Writing: An Overview viii
Chapter 14 Integrated Clinical Documentation. ........................................................................................125
By Lisa DeTora, PhD and Danny A. Benau, MSOD, PhD
Chapter 15 Investigator’s Brochure.............................................................................................................145
By Deborah Leonard, RN, MS
Chapter 16 Labeling. ..................................................................................................................................151
By Tina O’Brien, MS, RAC
Chapter 17 Background Packages...............................................................................................................159
By Jocelyn Jennings, MS, RAC
Chapter 18 Responses to Questions or Requests for Information. .............................................................171
By Nathalie Innocent, MS, RAC
Chapter 19 Interdisciplinary Document, Dossier Maintenance..................................................................179
By Evelyn De La Vega Stewart, MSc, RAC
Chapter 20 Value Dossiers. .........................................................................................................................185
By E. Mitchell Seymour, PhD, RAC, Kayla Ambroziak, PharmD, and Gert Bos, MSc, PhD, FRAPS
Chapter 21 Vaccines and Biologics. ............................................................................................................189
By Lisa DeTora, PhD
Chapter 22 Biosimilars: Special Considerations. ........................................................................................203
By Monica Ramchandani, MS, PhD
Chapter 23 Combination Product Design and Development.....................................................................215
By Jiaying Shen, PhD
Chapter 24 Rare Diseases—Special Considerations for Orphan Designations. .........................................225
By Beth Silverstein, MS, RAC and Jocelyn Jennings, MS, RAC
Chapter 25 Pediatric Investigational Plan (PIP).........................................................................................237
By Jocelyn Jennings, MS, RAC
Chapter 26 Accelerated Filings...................................................................................................................245
By Joanne Rupprecht, Esq, RAC and Siegfried Schmitt, PhD
Chapter 27 Publications..............................................................................................................................253
By Eileen M. Girten, MS
Chapter 28 Literature Reviews. ..................................................................................................................259
By Michelle Carey, PhD
Chapter 29 Lay Summaries of Clinical Study Results. ...............................................................................265
By Thomas M. Schindler, PhD
Chapter 30 Future Directions for Regulatory Writing................................................................................277
By Steve Carr and Helle Gawrylewski
Chapter 14 Integrated Clinical Documentation. ........................................................................................125
By Lisa DeTora, PhD and Danny A. Benau, MSOD, PhD
Chapter 15 Investigator’s Brochure.............................................................................................................145
By Deborah Leonard, RN, MS
Chapter 16 Labeling. ..................................................................................................................................151
By Tina O’Brien, MS, RAC
Chapter 17 Background Packages...............................................................................................................159
By Jocelyn Jennings, MS, RAC
Chapter 18 Responses to Questions or Requests for Information. .............................................................171
By Nathalie Innocent, MS, RAC
Chapter 19 Interdisciplinary Document, Dossier Maintenance..................................................................179
By Evelyn De La Vega Stewart, MSc, RAC
Chapter 20 Value Dossiers. .........................................................................................................................185
By E. Mitchell Seymour, PhD, RAC, Kayla Ambroziak, PharmD, and Gert Bos, MSc, PhD, FRAPS
Chapter 21 Vaccines and Biologics. ............................................................................................................189
By Lisa DeTora, PhD
Chapter 22 Biosimilars: Special Considerations. ........................................................................................203
By Monica Ramchandani, MS, PhD
Chapter 23 Combination Product Design and Development.....................................................................215
By Jiaying Shen, PhD
Chapter 24 Rare Diseases—Special Considerations for Orphan Designations. .........................................225
By Beth Silverstein, MS, RAC and Jocelyn Jennings, MS, RAC
Chapter 25 Pediatric Investigational Plan (PIP).........................................................................................237
By Jocelyn Jennings, MS, RAC
Chapter 26 Accelerated Filings...................................................................................................................245
By Joanne Rupprecht, Esq, RAC and Siegfried Schmitt, PhD
Chapter 27 Publications..............................................................................................................................253
By Eileen M. Girten, MS
Chapter 28 Literature Reviews. ..................................................................................................................259
By Michelle Carey, PhD
Chapter 29 Lay Summaries of Clinical Study Results. ...............................................................................265
By Thomas M. Schindler, PhD
Chapter 30 Future Directions for Regulatory Writing................................................................................277
By Steve Carr and Helle Gawrylewski