Regulatory Writing: An Overview x
Table 16-1. User Profile Examples ..............................................................................................................153
Table 16-2. Common Labeling Elements....................................................................................................155
Table 16-3. Labeling Risk Category Statements. ........................................................................................156
Table 17-1. FDA Meeting Types and Deadlines. ........................................................................................161
Table 17-2. Tips for Formulating Questions. ..............................................................................................162
Table 17-3. Sponsor/Applicant-Areas That may Lead to Questions. ..........................................................164
Table 17-4. 510(k) Submission Questions...................................................................................................167
Table 17-5. PMA Submission Questions. ...................................................................................................168
Table 19-1. IDE Annual Report Contents..................................................................................................182
Table 19-2. PMA Annual Report Contents. ...............................................................................................182
Table 19-3. IND Annual Report Contents..................................................................................................182
Table 19-4. ANDA/NDA Annual Report Contents...................................................................................182
Table 20-1. AMCP Format. ........................................................................................................................187
Table 20-2. Comparison of AMCP Dossier and International HTA..........................................................187
Table 20-3. Team Members and Their Responsibilities. ..............................................................................188
Table 21-1. Some Current US Biological Product Definitions....................................................................191
Table 21-2. EMA Biologics Definitions......................................................................................................192
Table 21-3. US Biologics Regulation (1902–2020) Selected Important Developments. .............................194
Table 21-4. Division of Products Between CDER and CBER Under the 1991 Intercenter Agreement. ...196
Table 22-1. Approved Biosimilars in the US ..............................................................................................204
Table 22-2. Differences in Regulatory Requirements for Reference Products, Generics, and
Biosimilars. ...............................................................................................................................206
Table 24-1. Available Resources..................................................................................................................232
Table 25-1. Pediatric Population..................................................................................................................238
Table 25-2. PIP Submission Process............................................................................................................241
Table 26-1. Comparison of Expedited Programs for Serious Conditions....................................................247
Table 26-2. EMA Accelerated Marketing Authorisation Pathways............................................................250
Table 27-1. Common Publication Deliverables. ..........................................................................................254
Table 27-2. Differences Between Regulatory and Publications Writing......................................................255
Table 27-3. Transparency Initiatives Affecting Publications Writing. .........................................................256
Table 28-1. Narrative Versus Systematic Reviews........................................................................................260
Table 28-2. Examples of Electronic Information Sources............................................................................261
Table 29-1. Content of Lay Summaries According to Annex V of EU CTR. ............................................267
Table 29-2. Summary of the European Expert Group Recommendations for Structuring a
Lay Summary. ..........................................................................................................................268
Table 29-3. MRCT Guidance on Timing of Information on Lay Summaries............................................269
Table 29-4. Comparison of EU Clinical Trial Regulation and Expert Group Recommendations
With MRCT Guidance............................................................................................................270
Table 16-1. User Profile Examples ..............................................................................................................153
Table 16-2. Common Labeling Elements....................................................................................................155
Table 16-3. Labeling Risk Category Statements. ........................................................................................156
Table 17-1. FDA Meeting Types and Deadlines. ........................................................................................161
Table 17-2. Tips for Formulating Questions. ..............................................................................................162
Table 17-3. Sponsor/Applicant-Areas That may Lead to Questions. ..........................................................164
Table 17-4. 510(k) Submission Questions...................................................................................................167
Table 17-5. PMA Submission Questions. ...................................................................................................168
Table 19-1. IDE Annual Report Contents..................................................................................................182
Table 19-2. PMA Annual Report Contents. ...............................................................................................182
Table 19-3. IND Annual Report Contents..................................................................................................182
Table 19-4. ANDA/NDA Annual Report Contents...................................................................................182
Table 20-1. AMCP Format. ........................................................................................................................187
Table 20-2. Comparison of AMCP Dossier and International HTA..........................................................187
Table 20-3. Team Members and Their Responsibilities. ..............................................................................188
Table 21-1. Some Current US Biological Product Definitions....................................................................191
Table 21-2. EMA Biologics Definitions......................................................................................................192
Table 21-3. US Biologics Regulation (1902–2020) Selected Important Developments. .............................194
Table 21-4. Division of Products Between CDER and CBER Under the 1991 Intercenter Agreement. ...196
Table 22-1. Approved Biosimilars in the US ..............................................................................................204
Table 22-2. Differences in Regulatory Requirements for Reference Products, Generics, and
Biosimilars. ...............................................................................................................................206
Table 24-1. Available Resources..................................................................................................................232
Table 25-1. Pediatric Population..................................................................................................................238
Table 25-2. PIP Submission Process............................................................................................................241
Table 26-1. Comparison of Expedited Programs for Serious Conditions....................................................247
Table 26-2. EMA Accelerated Marketing Authorisation Pathways............................................................250
Table 27-1. Common Publication Deliverables. ..........................................................................................254
Table 27-2. Differences Between Regulatory and Publications Writing......................................................255
Table 27-3. Transparency Initiatives Affecting Publications Writing. .........................................................256
Table 28-1. Narrative Versus Systematic Reviews........................................................................................260
Table 28-2. Examples of Electronic Information Sources............................................................................261
Table 29-1. Content of Lay Summaries According to Annex V of EU CTR. ............................................267
Table 29-2. Summary of the European Expert Group Recommendations for Structuring a
Lay Summary. ..........................................................................................................................268
Table 29-3. MRCT Guidance on Timing of Information on Lay Summaries............................................269
Table 29-4. Comparison of EU Clinical Trial Regulation and Expert Group Recommendations
With MRCT Guidance............................................................................................................270