Consultation record
Submissions accepted
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
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Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-CERTAINTY-FR/009 | Draft revision of the Institute’s certainty assessment framework… | Dr Hortensia Larsson-Ekwueme | It is not clear which provisions bind the assessment committee |
| DRAFT-CERTAINTY-FR/001 | Draft revision of the Institute’s certainty assessment framework… | Dr Bertrand Steenkamp-Ferreira | The search date is not on the face of the document |
| DRAFT-CERTAINTY-FR/015 | Draft revision of the Institute’s certainty assessment framework… | Dr Mordecai Glendinning-Uche | Quantitative claims are reproduced without the method that produced them |
| DRAFT-CERTAINTY-FR/003 | Draft revision of the Institute’s certainty assessment framework… | Dr Ivo Quintanilha | Registry records without posted results are neither screened nor counted |
| DRAFT-CERTAINTY-FR/007 | Draft revision of the Institute’s certainty assessment framework… | Dr Ludmila Castellanos-Reid | Indirectness is defined so broadly that any evidence could be downgraded under it |
| DRAFT-CERTAINTY-FR/014 | Draft revision of the Institute’s certainty assessment framework… | Dr Ivo Quintanilha | The rating conflates absence of evidence with conflicting evidence |
| DRAFT-SUPPLIER-RUB/002 | Draft supplier evaluation rubric | Dr Wilhelmina Erlingsson | The same concept is given three different names in one document |
| DRAFT-SUPPLIER-RUB/010 | Draft supplier evaluation rubric | Nkechi Larsson-Ekwueme | A rubric score will be read as a statement about product quality |
| DRAFT-SUPPLIER-RUB/009 | Draft supplier evaluation rubric | Vittoria Quintanilha | A dossier rests on a small number of documents and does not say how many |
| DRAFT-SUPPLIER-RUB/004 | Draft supplier evaluation rubric | Ignatius Erlingsson | Quantitative claims are reproduced without the method that produced them |
| DRAFT-SUPPLIER-RUB/005 | Draft supplier evaluation rubric | Dr Oisín Marchetti-Bassey | The search date is not on the face of the document |
| DRAFT-COA-MINIMUM-/012 | Draft certificate-of-analysis minimum data standard | Nkechi Larsson-Ekwueme | The search date is not on the face of the document |
| DRAFT-COA-MINIMUM-/008 | Draft certificate-of-analysis minimum data standard | Ludmila Brackenridge | The standard would be applied more consistently with a worked example |
| DRAFT-COA-MINIMUM-/003 | Draft certificate-of-analysis minimum data standard | Dr Kamila Glendinning-Uche | Quantitative claims are reproduced without the method that produced them |
| DRAFT-COA-MINIMUM-/006 | Draft certificate-of-analysis minimum data standard | Dr Marisol Dunmore-Ekpo | The standard does not say what to do with a result outside the expected range |
| DRAFT-COA-MINIMUM-/013 | Draft certificate-of-analysis minimum data standard | Dr Ndidi Ravensworth-Ilunga | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-COA-MINIMUM-/001 | Draft certificate-of-analysis minimum data standard | Dr Matthias Whitmarsh-Obi | Terms are used in senses that differ from established pharmacopoeial usage |
| DRAFT-COA-MINIMUM-/002 | Draft certificate-of-analysis minimum data standard | Dr Wilhelmina Wintringham | The limitations section states what the method cannot do but not what a reader will wrongly conclude |
| DRAFT-RP-HPLC-PURI/002 | Draft standard: determination of chromatographic purity by… | Brigitta Grünbaum-Sowande | The same concept is given three different names in one document |
| DRAFT-SEMAGLUTIDE-/009 | Draft monograph: semaglutide, version 3 | Dr Rukayat Zaleski-Mbeki | Registered trials that never reported are absent from the monograph |
| DRAFT-SEMAGLUTIDE-/004 | Draft monograph: semaglutide, version 3 | Dr Wolfram Kaltenbach-Mensah | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-SEMAGLUTIDE-/010 | Draft monograph: semaglutide, version 3 | Rosalind Petrossian | The search date is not on the face of the document |
| DRAFT-SEMAGLUTIDE-/013 | Draft monograph: semaglutide, version 3 | Dr Hyacinth Oyelaran-Steen | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-SEMAGLUTIDE-/002 | Draft monograph: semaglutide, version 3 | Dr Zebedee Zaleski-Mbeki | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-SEMAGLUTIDE-/001 | Draft monograph: semaglutide, version 3 | Dr Ottoline Fitzgerald-Nwosu | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-SEMAGLUTIDE-/005 | Draft monograph: semaglutide, version 3 | Dr Ludmila Tollemache | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-SEMAGLUTIDE-/008 | Draft monograph: semaglutide, version 3 | Dr Liesbeth Quenneville | The indication table mixes approved indications with uses for which the compound is merely supplied |
| DRAFT-SEMAGLUTIDE-/012 | Draft monograph: semaglutide, version 3 | Professor Ekaterina Voskresenskaya-Hill | Regulatory status is stated without naming the jurisdiction |
| DRAFT-SEMAGLUTIDE-/014 | Draft monograph: semaglutide, version 3 | Dr Amara Vandergraaf industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-TIRZEPATIDE-/005 | Draft monograph: tirzepatide, version 2 | Dr Ludmila Tollemache | Registered trials that never reported are absent from the monograph |
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