Consultation record
Submissions accepted — page 10
The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission.
Submissions
681 documents · page 10 of 23
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-CJC-1295-MON/006 | Draft monograph: CJC-1295 | Vasilisa Sandringham-Adu | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-DSIP-MONOGRA/001 | Draft monograph: DSIP | Radoslava Palmgren-Kofi | Regulatory status is stated without naming the jurisdiction |
| DRAFT-DSIP-MONOGRA/003 | Draft monograph: DSIP | Dr Melisande Thorsby-Nakamura industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-DSIP-MONOGRA/002 | Draft monograph: DSIP | Dr Sigrún Lavrentiev | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-DSIP-MONOGRA/004 | Draft monograph: DSIP | Dr Yehudit Yorkstone | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-DULAGLUTIDE-/007 | Draft monograph: Dulaglutide | Dr Ottoline Oppenheimer-Ade industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-DULAGLUTIDE-/011 | Draft monograph: Dulaglutide | Dr Piotr Hollingworth | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-DULAGLUTIDE-/006 | Draft monograph: Dulaglutide | Dr Delphine Trelawney | Registered trials that never reported are absent from the monograph |
| DRAFT-DULAGLUTIDE-/005 | Draft monograph: Dulaglutide | Dr Quentin Whitmarsh-Obi | What happens when the compound is stopped is not addressed |
| DRAFT-DULAGLUTIDE-/004 | Draft monograph: Dulaglutide | Dr Jerome Petrossian | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-DULAGLUTIDE-/009 | Draft monograph: Dulaglutide | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction |
| DRAFT-DULAGLUTIDE-/008 | Draft monograph: Dulaglutide | Dr Hortensia Larsson-Ekwueme | Effect estimates are given without naming the comparator |
| DRAFT-DULAGLUTIDE-/001 | Draft monograph: Dulaglutide | Dr Theodora Ingelbrecht | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-ECNOGLUTIDE-/003 | Draft monograph: Ecnoglutide | Dr Sigrún Lavrentiev | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-ECNOGLUTIDE-/004 | Draft monograph: Ecnoglutide | Radoslava Palmgren-Kofi | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-ECNOGLUTIDE-/002 | Draft monograph: Ecnoglutide | Dr Mordecai Bellingham-Ojo industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-ECNOGLUTIDE-/007 | Draft monograph: Ecnoglutide | Dr Lorcan Zaleski-Mbeki | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-EPITHALON-MO/005 | Draft monograph: Epithalon | Dr Séverine Oduya-Kaltenbrunner | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-EPITHALON-MO/003 | Draft monograph: Epithalon | Dr Amara Vandergraaf | Regulatory status is stated without naming the jurisdiction |
| DRAFT-EPITHALON-MO/002 | Draft monograph: Epithalon | Dr Prosper Vercingetorix | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-EXENATIDE-MO/002 | Draft monograph: Exenatide | Ms Rhiannon Okoye-Vandergraaf | Regulatory status is stated without naming the jurisdiction |
| DRAFT-EXENATIDE-MO/001 | Draft monograph: Exenatide | Dr Fenella Steenkamp-Ferreira | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-EXENATIDE-MO/004 | Draft monograph: Exenatide | Dr Stellan Cholmondeley-Ade industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-EXENATIDE-MO/006 | Draft monograph: Exenatide | Dr Ilona Mbatha-Fredriksen | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-EXENATIDE-MO/007 | Draft monograph: Exenatide | Dr Lorcan Whitmarsh-Obi | Effect estimates are given without naming the comparator |
| DRAFT-GHK-CU-MONOG/003 | Draft monograph: GHK-Cu | Dr Yehudit Yorkstone | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-GHK-CU-MONOG/006 | Draft monograph: GHK-Cu | Radoslava Palmgren-Kofi | Regulatory status is stated without naming the jurisdiction |
| DRAFT-GHK-CU-MONOG/004 | Draft monograph: GHK-Cu | Dr Melisande Thorsby-Nakamura industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-GHK-CU-MONOG/002 | Draft monograph: GHK-Cu | Dr Lorcan Uttridge | What happens when the compound is stopped is not addressed |
| DRAFT-GHK-CU-MONOG/005 | Draft monograph: GHK-Cu | Dr Sigrún Lavrentiev | Every contributing trial shares one sponsor and the monograph does not say so |
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