Consultation record
Submissions accepted — page 18
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
735 documents · page 18 of 25
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-SURVODUTIDE-/003 | Draft monograph: Survodutide | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction |
| DRAFT-SURVODUTIDE-/004 | Draft monograph: Survodutide | Dr Marisol Dunmore-Ekpo | Open-label extension data are presented alongside randomised data without distinction |
| DRAFT-SURVODUTIDE-/005 | Draft monograph: Survodutide | Dr Matthias Whitmarsh-Obi | Nothing is said about impaired renal or hepatic clearance |
| DRAFT-SURVODUTIDE-/006 | Draft monograph: Survodutide | Georgiana Zimmerthal | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-SURVODUTIDE-/007 | Draft monograph: Survodutide | Dr Piotr Hollingworth | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-SURVODUTIDE-/009 | Draft monograph: Survodutide | Dr Zdenka Ximenes | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-SURVODUTIDE-/011 | Draft monograph: Survodutide | Dr Adaeze Underhill-Okafor | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-SURVODUTIDE-/012 | Draft monograph: Survodutide | Dr Henrike Jastrzębska | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-SURVODUTIDE-/013 | Draft monograph: Survodutide | Dr Nikolai Yeovil-Bakare | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-SURVODUTIDE-/014 | Draft monograph: Survodutide | Dr Liesbeth Nordhagen industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-TB-500-MONOG/002 | Draft monograph: TB-500 | Dr Frideswide Grünbaum-Sowande | The absence of paediatric evidence is not stated where a reader would look for it |
| DRAFT-TB-500-MONOG/005 | Draft monograph: TB-500 | Dr Odalys Thorsby-Nakamura | Open-label extension data are presented alongside randomised data without distinction |
| DRAFT-TB-500-MONOG/006 | Draft monograph: TB-500 | Dr Mordecai Bellingham-Ojo | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-TB-500-MONOG/007 | Draft monograph: TB-500 | Quentin Whitmarsh-Obi | The compound is supplied under names the monograph does not list |
| DRAFT-TB-500-MONOG/008 | Draft monograph: TB-500 | Dr Vittoria Quintanilha | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-TEDUGLUTIDE-/001 | Draft monograph: Teduglutide | Dr Matthias Whitmarsh-Obi | Nothing is said about impaired renal or hepatic clearance |
| DRAFT-TEDUGLUTIDE-/002 | Draft monograph: Teduglutide | Dr Zdenka Nyquist-Obiora | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-TEDUGLUTIDE-/003 | Draft monograph: Teduglutide | Ivo Mountstephen | The search date is not on the face of the document |
| DRAFT-TEDUGLUTIDE-/005 | Draft monograph: Teduglutide | Dr Liesbeth Zaleski-Mbeki | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-TEDUGLUTIDE-/006 | Draft monograph: Teduglutide | Dr Zdenka Ximenes | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-TEDUGLUTIDE-/007 | Draft monograph: Teduglutide | Dr Hyacinth Drakeford-Amadi | Doses are expressed in units that differ between sections |
| DRAFT-TESAMORELIN-/003 | Draft monograph: Tesamorelin | Dr Eamon Immelmann | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-TESAMORELIN-/005 | Draft monograph: Tesamorelin | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction |
| DRAFT-TESAMORELIN-/006 | Draft monograph: Tesamorelin | Dr Ndidi Ravensworth-Ilunga | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-TESAMORELIN-/008 | Draft monograph: Tesamorelin | Dr Nadezhda Lavrentiev | The difference between pulsatile and continuous administration is not addressed |
| DRAFT-TESAMORELIN-/010 | Draft monograph: Tesamorelin | Ivo Mountstephen | The search date is not on the face of the document |
| DRAFT-TESAMORELIN-/013 | Draft monograph: Tesamorelin | Dr Melisande Thorsby-Nakamura | The analytical section assumes a reference standard that is not generally available |
| DRAFT-TESAMORELIN-/015 | Draft monograph: Tesamorelin | Dr Lorcan Zaleski-Mbeki | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-THYMALIN-MON/003 | Draft monograph: Thymalin | Dr Rosalind Petrossian | Doses are expressed in units that differ between sections |
| DRAFT-THYMALIN-MON/004 | Draft monograph: Thymalin | Dr Leonhard Quenneville | The pharmacokinetic section does not connect half-life to the dosing schedule |
page 18 of 25