Consultation record
Submissions accepted — page 16
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 16 of 23
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-SS-31-MONOGR/004 | Draft monograph: SS-31 (elamipretide) | Dr Wilhelmina Quaresma | Doses are expressed in units that differ between sections |
| DRAFT-SURVODUTIDE-/001 | Draft monograph: Survodutide | Dr Emiliana Ollerenshaw | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-SURVODUTIDE-/009 | Draft monograph: Survodutide | Dr Nadezhda Lavrentiev | Regulatory status is stated without naming the jurisdiction |
| DRAFT-SURVODUTIDE-/002 | Draft monograph: Survodutide | Dr Quentin Enthoven | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-SURVODUTIDE-/010 | Draft monograph: Survodutide | Dr Xenia Uttridge | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-SURVODUTIDE-/008 | Draft monograph: Survodutide | Dr Prosper Vercingetorix | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-SURVODUTIDE-/011 | Draft monograph: Survodutide | Dr Fitzwilliam Danquah-Öberg | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-SURVODUTIDE-/012 | Draft monograph: Survodutide | Adaeze Underhill-Okafor | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-SURVODUTIDE-/013 | Draft monograph: Survodutide | Gaspard Kettlewell | The analytical section assumes a reference standard that is not generally available |
| DRAFT-SURVODUTIDE-/003 | Draft monograph: Survodutide | Dr Séverine Oduya-Kaltenbrunner | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-TB-500-MONOG/002 | Draft monograph: TB-500 | Dr Lorcan Whitmarsh-Obi | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-TB-500-MONOG/004 | Draft monograph: TB-500 | Dr Leonhard Quenneville | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-TB-500-MONOG/007 | Draft monograph: TB-500 | Ms Rhiannon Okoye-Vandergraaf industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-TB-500-MONOG/001 | Draft monograph: TB-500 | Dr Kolawole Isaksen-Balogun | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-TB-500-MONOG/008 | Draft monograph: TB-500 | Dr Fenella Steenkamp-Ferreira | Effect estimates are given without naming the comparator |
| DRAFT-TEDUGLUTIDE-/002 | Draft monograph: Teduglutide | Dr Vittoria Ylönen | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-TEDUGLUTIDE-/001 | Draft monograph: Teduglutide | Dr Mordecai Glendinning-Uche | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-TEDUGLUTIDE-/007 | Draft monograph: Teduglutide | Dr Vasilisa Immelmann | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-TESAMORELIN-/001 | Draft monograph: Tesamorelin | Dr Oswin Yorkstone | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-TESAMORELIN-/007 | Draft monograph: Tesamorelin | Dr Ivo Quintanilha | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-TESAMORELIN-/011 | Draft monograph: Tesamorelin | Dr Jolanta Uttridge industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-TESAMORELIN-/008 | Draft monograph: Tesamorelin | Dr Katarzyna Oppenheimer-Ade | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-TESAMORELIN-/009 | Draft monograph: Tesamorelin | Dr Jerome Petrossian | The search date is not on the face of the document |
| DRAFT-TESAMORELIN-/006 | Draft monograph: Tesamorelin | Dr Anselm Ashworth-Danquah | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-THYMALIN-MON/006 | Draft monograph: Thymalin | Dr Hyacinth Oyelaran-Steen | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-THYMALIN-MON/003 | Draft monograph: Thymalin | Dr Ngozi Zetterlund | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-THYMALIN-MON/008 | Draft monograph: Thymalin | Dr Prosper Vercingetorix | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-THYMOSIN-ALP/013 | Draft monograph: Thymosin alpha-1 | Dr Abimbola Sotomayor-Ekwueme | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-THYMOSIN-ALP/005 | Draft monograph: Thymosin alpha-1 | Radoslava Palmgren-Kofi | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-THYMOSIN-ALP/009 | Draft monograph: Thymosin alpha-1 | Dr Dmitri Nordhagen | Adverse event frequencies are given without the denominator or the exposure period |
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