Public comment periods
120 consultations carrying 1,332 signed submissions. Every submission has a declared interest, a secretariat response and a disposition.
The Institute releases drafts for public comment before ratification. This is its only community surface and it is deliberately formal.
A submission is a signed document with declared interests. It is answered by the secretariat and given a disposition: accepted, accepted in part, noted without amendment, or not accepted with a stated reason. Submissions that are not accepted remain published in full, because a consultation record that shows only the arguments the Institute agreed with is not a consultation record.
11 consultations are currently open. Submissions are made in writing to the secretariat and must carry the respondent's name, credentials, affiliation and declared interests. The Institute holds no telephone number and uses no messaging channel.
Consultations
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Consultation on the draft certainty index, a cross-cutting finding aid that lists every assessed outcome in the document set by its certainty rating. The index makes it possible to see, in one place, how much of the Institute's output…
15 submissions -
Consultation on the draft of this intervention review, which registers the question: What randomised evidence supports mitochondria-targeted peptides in primary mitochondrial disease and in age-related functional decline?
12 submissions1 not accepted -
Consultation on the draft monograph for SS-31 (elamipretide), 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…
16 submissions4 not accepted -
Consultation on the draft of CEI-MS-13, which specifies the performance a determination must achieve for method validation and states what the resulting figure does not establish. The draft states performance rather than prescribing a…
13 submissions5 not accepted -
Consultation on the fourth version of the Institute's methodology document, which describes how a question is registered, how evidence is searched and screened, how certainty is rated, how a document is reviewed and ratified, and how it is…
21 submissions3 not accepted -
Consultation on the draft of this analytical evidence review, which registers the question: How much does a reported chromatographic purity figure vary with the method used to obtain it?
4 submissions -
Consultation on the draft monograph for CJC-1295, 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…
13 submissions -
Consultation on the draft monograph for amycretin, a co-agonist at the glucagon-like peptide-1 and amylin receptors. The draft grades the principal assessed outcome at low certainty on the basis of early-phase evidence, and records that no…
16 submissions1 not accepted -
Consultation on the draft monograph for Exenatide, 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 submissions2 not accepted -
Consultation on the draft of CEI-MS-07, 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 draft of this analytical evidence review, which registers the question: What is known about bacterial endotoxin content in peptides supplied for research and injected in practice?
2 submissions -
Consultation on the draft scoping review of change in lean mass during pharmacologically induced weight reduction. The review is scoping rather than an intervention review because the contributing studies measure body composition by…
7 submissions -
Consultation on the draft of CEI-MS-20, which specifies the performance a determination must achieve for stability and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
4 submissions1 not accepted -
Consultation on the draft monograph for orforglipron, an oral non-peptide glucagon-like peptide-1 receptor agonist. The draft assesses a compound whose phase 3 programme was reporting during the consultation window, and grades the…
10 submissions2 not accepted -
Consultation on the draft monograph for Sermorelin, 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…
9 submissions -
Consultation on the draft synthesis of incretin receptor agonists for metabolic dysfunction-associated steatohepatitis. The anchor outcome is histological, which raises the question the consultation was principally about: whether a…
12 submissions1 not accepted -
Consultation on the draft monograph for KPV, 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…
15 submissions1 not accepted -
Consultation on the draft monograph for PT-141 (bremelanotide), 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…
17 submissions1 not accepted -
Consultation on the draft monograph for Pramlintide, 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 submissions2 not accepted -
Consultation on the draft monograph for MOTS-c, 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…
8 submissions1 not accepted
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