Consultation record
Submissions accepted in part — page 6
Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined.
Submissions
377 documents · page 6 of 13
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-CAGRILINTIDE/009 | Draft monograph: Cagrilintide | Dr Bertrand Steenkamp-Ferreira | Trials are described as terminated where they completed as planned |
| DRAFT-CAGRILINTIDE/015 | Draft monograph: Cagrilintide | Dr Quentin Whitmarsh-Obi industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-CAGRILINTIDE/016 | Draft monograph: Cagrilintide | Dr Delphine Trelawney | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-CJC-1295-MON/011 | Draft monograph: CJC-1295 | Dr Fenella Steenkamp-Ferreira | Trials are described as terminated where they completed as planned |
| DRAFT-CJC-1295-MON/009 | Draft monograph: CJC-1295 | Dr Jerome Lavrentiev | The recorded evidence gaps omit outcomes a reader would consider material |
| DRAFT-CJC-1295-MON/008 | Draft monograph: CJC-1295 | Dr Séverin Oppenheimer-Ade | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-CJC-1295-MON/013 | Draft monograph: CJC-1295 | Xiomara Fairweather-Duru | References should carry a persistent identifier for every cited source |
| DRAFT-DULAGLUTIDE-/002 | Draft monograph: Dulaglutide | Dr Quintus Kettlewell | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-DULAGLUTIDE-/003 | Draft monograph: Dulaglutide | Dr Theodora Ximenes industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-DULAGLUTIDE-/010 | Draft monograph: Dulaglutide | Dr Ludmila Castellanos-Reid | Trials are described as terminated where they completed as planned |
| DRAFT-EPITHALON-MO/004 | Draft monograph: Epithalon | Dr Hyacinth Oyelaran-Steen | Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… |
| DRAFT-EXENATIDE-MO/008 | Draft monograph: Exenatide | Dr Kolawole Isaksen-Balogun | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-GHK-CU-MONOG/001 | Draft monograph: GHK-Cu | Dr Jacinta Grünbaum-Sowande | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-GHRP-2-MONOG/007 | Draft monograph: GHRP-2 | Adaeze Underhill-Okafor | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-GHRP-6-MONOG/001 | Draft monograph: GHRP-6 | Yusuf Whitmarsh-Obi | Anti-drug antibody data are omitted |
| DRAFT-GHRP-6-MONOG/004 | Draft monograph: GHRP-6 | Dr Wolfram Kaltenbach-Mensah | Trials are described as terminated where they completed as planned |
| DRAFT-GHRP-6-MONOG/009 | Draft monograph: GHRP-6 | Dr Ludmila Tollemache industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-GHRP-6-MONOG/010 | Draft monograph: GHRP-6 | Dr Jolyon Grünbaum-Sowande | The preclinical section is extensive and the clinical section is not |
| DRAFT-GLUTATHIONE-/007 | Draft monograph: Glutathione | Dr Stellan Cholmondeley-Ade | Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… |
| DRAFT-GLUTATHIONE-/004 | Draft monograph: Glutathione | Dr Lorcan Whitmarsh-Obi | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-GLUTATHIONE-/006 | Draft monograph: Glutathione | Dr Fenella Steenkamp-Ferreira | The preclinical section is extensive and the clinical section is not |
| DRAFT-GLUTATHIONE-/003 | Draft monograph: Glutathione | Dr Kolawole Isaksen-Balogun | The recorded evidence gaps omit outcomes a reader would consider material |
| DRAFT-GLUTATHIONE-/013 | Draft monograph: Glutathione | Dr Hyacinth Oyelaran-Steen | Trials are described as terminated where they completed as planned |
| DRAFT-GONADORELIN-/005 | Draft monograph: Gonadorelin | Dr Evander Whitmarsh-Obi | The recorded evidence gaps omit outcomes a reader would consider material |
| DRAFT-GONADORELIN-/007 | Draft monograph: Gonadorelin | Kolawole Oppenheimer-Ade industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-HEXARELIN-MO/003 | Draft monograph: Hexarelin | Dr Lorcan Uttridge | Point estimates are given without an interval |
| DRAFT-HEXARELIN-MO/004 | Draft monograph: Hexarelin | Dr Jacinta Grünbaum-Sowande | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-HEXARELIN-MO/002 | Draft monograph: Hexarelin | Dr Gaspard Wintringham | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-HEXARELIN-MO/007 | Draft monograph: Hexarelin | Dr Ursina Ellsworth-Vance | The recorded evidence gaps omit outcomes a reader would consider material |
| DRAFT-IGF-1-LR3-MO/006 | Draft monograph: IGF-1 LR3 | Dr Ivo Quintanilha | Trials are described as terminated where they completed as planned |
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