Public comment periods — page 3
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 scoping review of melanocortin receptor agonists, which maps the evidence across approved indications and the uses for which these compounds are supplied outside a regulated route. The review is scoping because…
11 submissions1 not accepted -
Consultation on the draft safety review of delayed gastric emptying and residual gastric content in patients receiving an incretin receptor agonist who present for procedural sedation. The review assesses a signal drawn largely from…
15 submissions1 not accepted -
Consultation on the draft monograph for Ipamorelin, 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…
10 submissions1 not accepted -
Consultation on the draft standard for bacterial endotoxin testing of peptide presentations, which specifies the performance a determination must achieve and the interference testing required before a result can be interpreted. The draft…
12 submissions1 not accepted -
Consultation on the draft of this analytical evidence review, which registers the question: What proportion of certificates of analysis supplied with research peptides contain the fields required to interpret the reported purity figure?
8 submissions -
Consultation on the draft monograph for CagriSema (cagrilintide with semaglutide), which the assessment committee released for public comment before ratification. The draft grades the compound's principal assessed outcome at moderate…
5 submissions1 not accepted -
Consultation on the draft synthesis of weight trajectory after an incretin receptor agonist is stopped. The contributing evidence is drawn principally from the randomised withdrawal designs in STEP 4, reported in JAMA in 2021, and…
16 submissions2 not accepted -
Consultation on the draft monograph for Thymalin, 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…
10 submissions1 not accepted -
Consultation on the draft monograph for Semax, 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 rating…
15 submissions -
Consultation on the draft monograph for Tesamorelin, 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…
15 submissions3 not accepted -
Consultation on the draft of CEI-MS-12, 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…
15 submissions2 not accepted -
Consultation on the draft analytical evidence review of published surveys of unregulated peptide supply. The review assesses what such surveys establish, and records that the great majority of them cannot establish the provenance of the…
14 submissions2 not accepted -
Consultation on the draft monograph for NAD+ (nicotinamide adenine dinucleotide), which the assessment committee released for public comment before ratification. The draft grades the compound's principal assessed outcome at very low…
9 submissions2 not accepted -
Consultation on the draft monograph for danuglipron, an oral non-peptide glucagon-like peptide-1 receptor agonist whose development programme was discontinued. The draft records the discontinuation and treats the resulting evidence as…
3 submissions -
Consultation on the draft monograph for DSIP, 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 that…
4 submissions -
Consultation on the draft monograph for Liraglutide, which the assessment committee released for public comment before ratification. The draft grades the compound's principal assessed outcome at high certainty and states the basis for that…
8 submissions -
Consultation on the draft of CEI-MS-09, 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…
13 submissions2 not accepted -
Consultation on the second version of the tirzepatide monograph, which incorporates the obesity evidence from SURMOUNT-1, reported in the New England Journal of Medicine in 2022, the withdrawal evidence from SURMOUNT-4, reported in JAMA in…
15 submissions1 not accepted -
Consultation on the comparison table that presents supplier dossiers side by side. The draft table shows only fields verified from a document the Institute holds, and the consultation was principally concerned with whether a sortable table…
14 submissions1 not accepted -
Consultation on the draft of this methodological review, which registers the question: To what extent does a change in body weight predict a change in the clinical outcomes for which weight reduction is undertaken?
9 submissions1 not accepted
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