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
390 documents · page 8 of 13
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-PETRELINTIDE/014 | Draft monograph: Petrelintide | Dr Jolanta Uttridge | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-PRAMLINTIDE-/003 | Draft monograph: Pramlintide | Dr Odalys Thorsby-Nakamura | Trials are described as terminated where they completed as planned |
| DRAFT-PRAMLINTIDE-/005 | Draft monograph: Pramlintide | Dr Jolanta Uttridge | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-PRAMLINTIDE-/012 | Draft monograph: Pramlintide | Dr Theodora Ingelbrecht | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-PRAMLINTIDE-/013 | Draft monograph: Pramlintide | Dr Hyacinth Drakeford-Amadi | The interaction section lists mechanisms rather than interactions |
| DRAFT-PT-141-MONOG/001 | Draft monograph: PT-141 (bremelanotide) | Dr Rosalind Petrossian | The interaction section lists mechanisms rather than interactions |
| DRAFT-PT-141-MONOG/008 | Draft monograph: PT-141 (bremelanotide) | Dr Jozef Brandvold-Achterberg | Trials are described as terminated where they completed as planned |
| DRAFT-PT-141-MONOG/011 | Draft monograph: PT-141 (bremelanotide) | Dr Kolawole Isaksen-Balogun | Point estimates are given without an interval |
| DRAFT-PT-141-MONOG/015 | Draft monograph: PT-141 (bremelanotide) | Dr Liesbeth Nyquist-Obiora | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-SELANK-MONOG/004 | Draft monograph: Selank | Dr Frideswide Nordhagen | The interaction section lists mechanisms rather than interactions |
| DRAFT-SELANK-MONOG/006 | Draft monograph: Selank | Dr Liesbeth Nordhagen industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-SEMAX-MONOGR/013 | Draft monograph: Semax | Dr Delphine Trelawney | The preclinical section is extensive and the clinical section is not |
| DRAFT-SEMAX-MONOGR/014 | Draft monograph: Semax | Bertrand Ollerenshaw industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-SERMORELIN-M/002 | Draft monograph: Sermorelin | Dr Perpetua Haverkamp-Diallo industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-SS-31-MONOGR/002 | Draft monograph: SS-31 (elamipretide) | Dr Perpetua Haverkamp-Diallo industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-SS-31-MONOGR/003 | Draft monograph: SS-31 (elamipretide) | Dr Piotr Hollingworth | The mechanism section is written with more confidence than the clinical section it precedes |
| DRAFT-SS-31-MONOGR/015 | Draft monograph: SS-31 (elamipretide) | Dr Zebedee Zaleski-Mbeki | Anti-drug antibody data are omitted |
| DRAFT-SS-31-MONOGR/016 | Draft monograph: SS-31 (elamipretide) | Dr Theodora Ingelbrecht | The preclinical section is extensive and the clinical section is not |
| DRAFT-SURVODUTIDE-/001 | Draft monograph: Survodutide | Dr Oisín Rautavaara | Point estimates are given without an interval |
| DRAFT-SURVODUTIDE-/010 | Draft monograph: Survodutide | Dr Rosalind Petrossian | The interaction section lists mechanisms rather than interactions |
| DRAFT-TB-500-MONOG/004 | Draft monograph: TB-500 | Dr Fenella Steenkamp-Ferreira | The interaction section lists mechanisms rather than interactions |
| DRAFT-TEDUGLUTIDE-/004 | Draft monograph: Teduglutide | Bertrand Ollerenshaw industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-TESAMORELIN-/002 | Draft monograph: Tesamorelin | Dr Marisol Dunmore-Ekpo | Trials are described as terminated where they completed as planned |
| DRAFT-TESAMORELIN-/007 | Draft monograph: Tesamorelin | Dr Piotr Hollingworth | The mechanism section is written with more confidence than the clinical section it precedes |
| DRAFT-TESAMORELIN-/011 | Draft monograph: Tesamorelin | Dr Liesbeth Nyquist-Obiora | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-TESAMORELIN-/014 | Draft monograph: Tesamorelin | Dr Leonhard Quenneville | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-THYMALIN-MON/002 | Draft monograph: Thymalin | Leonhard Achterberg | Anti-drug antibody data are omitted |
| DRAFT-THYMALIN-MON/005 | Draft monograph: Thymalin | Dr Henrike Jastrzębska | The preclinical section is extensive and the clinical section is not |
| DRAFT-THYMALIN-MON/006 | Draft monograph: Thymalin | Dr Kolawole Isaksen-Balogun | Point estimates are given without an interval |
| DRAFT-THYMALIN-MON/007 | Draft monograph: Thymalin | Dr Ndidi Ravensworth-Ilunga | Trials are described as terminated where they completed as planned |
page 8 of 13