Consultation record
Submissions accepted in part — page 7
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
390 documents · page 7 of 13
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-IPAMORELIN-M/004 | Draft monograph: Ipamorelin | Dr Frideswide Nordhagen | The interaction section lists mechanisms rather than interactions |
| DRAFT-IPAMORELIN-M/008 | Draft monograph: Ipamorelin | Dr Leonhard Quenneville | The preclinical section is extensive and the clinical section is not |
| DRAFT-KPV-MONOGRAP/004 | Draft monograph: KPV | Dr Zdenka Nyquist-Obiora | The mechanism section is written with more confidence than the clinical section it precedes |
| DRAFT-KPV-MONOGRAP/005 | Draft monograph: KPV | Dr Fenella Steenkamp-Ferreira | The interaction section lists mechanisms rather than interactions |
| DRAFT-KPV-MONOGRAP/011 | Draft monograph: KPV | Dr Henrike Jastrzębska | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-LARAZOTIDE-M/007 | Draft monograph: Larazotide acetate | Dr Hyacinth Drakeford-Amadi | The interaction section lists mechanisms rather than interactions |
| DRAFT-LIRAGLUTIDE-/005 | Draft monograph: Liraglutide | Dr Matthias Wintringham industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-LIRAGLUTIDE-/007 | Draft monograph: Liraglutide | Dr Lorcan Whitmarsh-Obi | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-LIXISENATIDE/002 | Draft monograph: Lixisenatide | Dr Hortensia Hollingworth | Anti-drug antibody data are omitted |
| DRAFT-LIXISENATIDE/007 | Draft monograph: Lixisenatide | Dr Kolawole Isaksen-Balogun | Point estimates are given without an interval |
| DRAFT-LIXISENATIDE/008 | Draft monograph: Lixisenatide | Dr Leonhard Quenneville | The preclinical section is extensive and the clinical section is not |
| DRAFT-LIXISENATIDE/009 | Draft monograph: Lixisenatide | Dr Wolfram Quintanilha industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-LL-37-MONOGR/003 | Draft monograph: LL-37 | Dr Lorcan Uttridge | Anti-drug antibody data are omitted |
| DRAFT-MARIDEBART-C/006 | Draft monograph: Maridebart cafraglutide | Dr Katarzyna Yorkstone | The cardiovascular result is reported without the population that generated it |
| DRAFT-MAZDUTIDE-MO/001 | Draft monograph: Mazdutide | Dr Adaeze Underhill-Okafor | Trials are described as terminated where they completed as planned |
| DRAFT-MAZDUTIDE-MO/002 | Draft monograph: Mazdutide | Dr Kolawole Isaksen-Balogun | Point estimates are given without an interval |
| DRAFT-MAZDUTIDE-MO/004 | Draft monograph: Mazdutide | Leonhard Achterberg | Anti-drug antibody data are omitted |
| DRAFT-MELANOTAN-II/003 | Draft monograph: Melanotan-II | Dr Piotr Hollingworth | The preclinical section is extensive and the clinical section is not |
| DRAFT-MELANOTAN-II/004 | Draft monograph: Melanotan-II | Dr Odalys Thorsby-Nakamura | Trials are described as terminated where they completed as planned |
| DRAFT-MOTS-C-MONOG/003 | Draft monograph: MOTS-c | Thaddeus Isaksen-Balogun | Point estimates are given without an interval |
| DRAFT-MOTS-C-MONOG/005 | Draft monograph: MOTS-c | Dr Zebedee Zaleski-Mbeki | Anti-drug antibody data are omitted |
| DRAFT-NAD-PLUS-MON/004 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Liesbeth Nordhagen industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-NAD-PLUS-MON/007 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Delphine Trelawney | The mechanism section is written with more confidence than the clinical section it precedes |
| DRAFT-ORAL-SEMAGLU/002 | Draft monograph: Semaglutide, oral | Leonhard Achterberg | Anti-drug antibody data are omitted |
| DRAFT-ORAL-SEMAGLU/009 | Draft monograph: Semaglutide, oral | Professor Ekaterina Voskresenskaya-Hill | Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… |
| DRAFT-PETRELINTIDE/004 | Draft monograph: Petrelintide | Ms Rhiannon Okoye-Vandergraaf | The document is unreadable without specialist training |
| DRAFT-PETRELINTIDE/005 | Draft monograph: Petrelintide | Dr Jozef Brandvold-Achterberg | Trials are described as terminated where they completed as planned |
| DRAFT-PETRELINTIDE/006 | Draft monograph: Petrelintide | Dr Oisín Rautavaara | Point estimates are given without an interval |
| DRAFT-PETRELINTIDE/007 | Draft monograph: Petrelintide | Dr Lorcan Uttridge | Anti-drug antibody data are omitted |
| DRAFT-PETRELINTIDE/010 | Draft monograph: Petrelintide | Dr Zdenka Nyquist-Obiora | The preclinical section is extensive and the clinical section is not |
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