Public comment periods — page 2
120 consultations carrying 1,332 signed submissions. Every submission has a declared interest, a secretariat response and a disposition.
Consultations
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Consultation on the draft monograph for Lixisenatide, which the assessment committee released for public comment before ratification. The draft grades the compound's principal assessed outcome at moderate certainty and states the basis for…
10 submissions1 not accepted -
Consultation on the draft standard for freeze–thaw and in-use stability assessment of reconstituted peptide solutions. The draft specifies the cycling regime, the hold conditions and the stability-indicating determinations required, and…
15 submissions1 not accepted -
Consultation on the draft of CEI-MS-04, which specifies the performance a determination must achieve for content and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
16 submissions -
Consultation on the draft synthesis of incretin receptor agonists in adolescents. The contributing evidence is small, drawn principally from the adolescent arm of the STEP programme reported in the New England Journal of Medicine in 2022…
16 submissions2 not accepted -
Consultation on the draft of CEI-MS-19, which specifies the performance a determination must achieve for chromatographic purity and states what the resulting figure does not establish. The draft states performance rather than prescribing a…
16 submissions3 not accepted -
Consultation on the second version of the synthesis of glucagon-like peptide-1 receptor agonists for weight reduction in adults with obesity. The revision re-runs the registered search, adds trials reported since the first version, and…
15 submissions1 not accepted -
Consultation on the draft monograph for 5-amino-1MQ, which the assessment committee released for public comment before ratification. The draft grades the compound's principal assessed outcome at very low certainty and states the basis for…
6 submissions1 not accepted -
Consultation on the draft of this network meta-analysis, which registers the question: In adults with obesity, does a multi-receptor incretin agonist produce a larger reduction in body weight than a single glucagon-like peptide-1 receptor…
7 submissions2 not accepted -
Consultation on the draft monograph for Thymosin beta-4, which the assessment committee released for public comment before ratification. The draft grades the compound's principal assessed outcome at low certainty and states the basis for…
15 submissions1 not accepted -
Consultation on the draft monograph for retatrutide, a triple agonist at the glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide and glucagon receptors. The principal assessed outcome is graded at low certainty because…
14 submissions3 not accepted -
Consultation on the draft of this analytical evidence review, which registers the question: What is the effect of reconstitution practice on the dose actually delivered from a lyophilised research peptide?
9 submissions1 not accepted -
Consultation on the draft methodological review of transitivity in the incretin network. The review examines whether the trials connecting these interventions through common comparators are similar enough in population, background therapy…
9 submissions1 not accepted -
Consultation on the draft monograph for Ecnoglutide, which the assessment committee released for public comment before ratification. The draft grades the compound's principal assessed outcome at low certainty and states the basis for that…
7 submissions1 not accepted -
Consultation on the draft monograph for Melanotan-II, which the assessment committee released for public comment before ratification. The draft grades the compound's principal assessed outcome at very low certainty and states the basis for…
4 submissions1 not accepted -
Consultation on the draft of CEI-MS-11, which specifies the performance a determination must achieve for physical quality and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
12 submissions1 not accepted -
Consultation on the draft of this methodological review, which registers the question: What can be concluded from a development programme that was discontinued, and how should the Institute record it?
3 submissions1 not accepted -
Consultation on the draft monograph for Epithalon, which the assessment committee released for public comment before ratification. The draft grades the compound's principal assessed outcome at very low certainty and states the basis for…
5 submissions1 not accepted -
Consultation on the draft of CEI-MS-08, which specifies the performance a determination must achieve for chromatographic purity and states what the resulting figure does not establish. The draft states performance rather than prescribing a…
9 submissions2 not accepted -
Consultation on the draft monograph for Mazdutide, which the assessment committee released for public comment before ratification. The draft grades the compound's principal assessed outcome at moderate certainty and states the basis for…
9 submissions1 not accepted -
Consultation on the draft of this scoping review, which registers the question: What clinical evidence supports the uses under which growth-hormone secretagogues are supplied for research?
9 submissions
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