Consultation record
Submissions accepted in part — page 8
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 8 of 13
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-PRAMLINTIDE-/009 | Draft monograph: Pramlintide | Nkechi Larsson-Ekwueme | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-PRAMLINTIDE-/010 | Draft monograph: Pramlintide | Vittoria Quintanilha industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-PRAMLINTIDE-/002 | Draft monograph: Pramlintide | Dr Kolawole Isaksen-Balogun | Anti-drug antibody data are omitted |
| DRAFT-PRAMLINTIDE-/005 | Draft monograph: Pramlintide | Xiomara Fairweather-Duru | The preclinical section is extensive and the clinical section is not |
| DRAFT-PT-141-MONOG/004 | Draft monograph: PT-141 (bremelanotide) | Dr Ilona Mbatha-Fredriksen | The recorded evidence gaps omit outcomes a reader would consider material |
| DRAFT-PT-141-MONOG/008 | Draft monograph: PT-141 (bremelanotide) | Ms Rhiannon Okoye-Vandergraaf | Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… |
| DRAFT-PT-141-MONOG/016 | Draft monograph: PT-141 (bremelanotide) | Kolawole Jankowiak-Osei | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-PT-141-MONOG/001 | Draft monograph: PT-141 (bremelanotide) | Dr Lorcan Whitmarsh-Obi | The preclinical section is extensive and the clinical section is not |
| DRAFT-SELANK-MONOG/006 | Draft monograph: Selank | Dr Sigrún Lavrentiev | The recorded evidence gaps omit outcomes a reader would consider material |
| DRAFT-SELANK-MONOG/002 | Draft monograph: Selank | Dr Lorcan Zaleski-Mbeki | Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… |
| DRAFT-SEMAX-MONOGR/014 | Draft monograph: Semax | Dr Katarzyna Oppenheimer-Ade | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-SEMAX-MONOGR/011 | Draft monograph: Semax | Dr Bertrand Steenkamp-Ferreira | Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… |
| DRAFT-SEMAX-MONOGR/012 | Draft monograph: Semax | Dr Anselm Ashworth-Danquah | The document is unreadable without specialist training |
| DRAFT-SEMAX-MONOGR/010 | Draft monograph: Semax | Dr Gaspard Wintringham | Trials are described as terminated where they completed as planned |
| DRAFT-SERMORELIN-M/008 | Draft monograph: Sermorelin | Dr Bertrand Steenkamp-Ferreira | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-SERMORELIN-M/003 | Draft monograph: Sermorelin | Dr Kamila Ubertini | The recorded evidence gaps omit outcomes a reader would consider material |
| DRAFT-SERMORELIN-M/002 | Draft monograph: Sermorelin | Dr Delphine Trelawney | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-SS-31-MONOGR/007 | Draft monograph: SS-31 (elamipretide) | Dr Wojciech Kaltenbach-Mensah | The preclinical section is extensive and the clinical section is not |
| DRAFT-SS-31-MONOGR/005 | Draft monograph: SS-31 (elamipretide) | Dr Abimbola Sotomayor-Ekwueme | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-SURVODUTIDE-/007 | Draft monograph: Survodutide | Professor Ekaterina Voskresenskaya-Hill industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-SURVODUTIDE-/005 | Draft monograph: Survodutide | Dr Amara Vandergraaf | Trials are described as terminated where they completed as planned |
| DRAFT-TB-500-MONOG/003 | Draft monograph: TB-500 | Dr Ilona Mbatha-Fredriksen industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-TB-500-MONOG/005 | Draft monograph: TB-500 | Dr Stellan Cholmondeley-Ade | Trials are described as terminated where they completed as planned |
| DRAFT-TEDUGLUTIDE-/003 | Draft monograph: Teduglutide | Dr Katarzyna Oppenheimer-Ade industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-TEDUGLUTIDE-/005 | Draft monograph: Teduglutide | Dr Anselm Ashworth-Danquah | Point estimates are given without an interval |
| DRAFT-TEDUGLUTIDE-/004 | Draft monograph: Teduglutide | Dr Ivo Quintanilha | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-TEDUGLUTIDE-/006 | Draft monograph: Teduglutide | Dr Bertrand Steenkamp-Ferreira | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-TESAMORELIN-/013 | Draft monograph: Tesamorelin | Dr Rukayat Zaleski-Mbeki | Trials are described as terminated where they completed as planned |
| DRAFT-TESAMORELIN-/003 | Draft monograph: Tesamorelin | Dr Ludmila Castellanos-Reid | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-TESAMORELIN-/002 | Draft monograph: Tesamorelin | Dr Kamila Ubertini | The recorded evidence gaps omit outcomes a reader would consider material |
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