Public comment periods — page 6
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 of this intervention review, which registers the question: Does the cardiovascular effect of a glucagon-like peptide-1 receptor agonist established in secondary prevention extend to a primary-prevention population?
10 submissions -
Consultation on the draft of CEI-MS-03, 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…
11 submissions2 not accepted -
Consultation on the draft of CEI-MS-15, which specifies the performance a determination must achieve for documentation and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
12 submissions2 not accepted -
Consultation on the draft monograph for Petrelintide, 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…
15 submissions -
Consultation on the draft monograph for GHRP-6, 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…
11 submissions2 not accepted -
Consultation on the format of the supplier dossier series: what a dossier contains, in what order, and what it declines to contain. The draft fixes a common structure so that two dossiers can be read against each other, and excludes any…
10 submissions1 not accepted -
Consultation on the draft monograph for BPC-157. The draft records that the Institute identified no completed randomised controlled trial in humans reporting a clinical outcome, and grades the principal assessed outcome at very low…
8 submissions1 not accepted -
Consultation on the draft monograph for Glutathione, 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…
14 submissions1 not accepted -
Consultation on the draft monograph for Cagrilintide, 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…
16 submissions -
Consultation on the draft monograph for Teduglutide, 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…
7 submissions -
Consultation on the draft of CEI-MS-02, which specifies the performance a determination must achieve for identity and states what the resulting figure does not establish. The draft states performance rather than prescribing a fixed…
6 submissions -
Consultation on the draft of this intervention review, which registers the question: In adults with heart failure with preserved ejection fraction and obesity, what is the effect of an incretin receptor agonist on symptoms and on…
4 submissions -
Consultation on the draft monograph for Maridebart cafraglutide, 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…
9 submissions1 not accepted -
Consultation on the scope and drafting conventions of the analytical and methodological standards series. The central question put was whether an Institute standard should prescribe a procedure or state the performance a determination must…
9 submissions1 not accepted -
Consultation on the draft standard specifying the minimum data a certificate of analysis must carry before the Institute will treat it as interpretable. The draft classifies each field as critical or recommended and records that a…
13 submissions1 not accepted -
Consultation on the set of indications the Institute assesses against and the anchor outcome defined for each. The draft fixes one anchor outcome per indication so that estimates carried in different documents are estimates of the same…
15 submissions1 not accepted -
Consultation on the rubric by which the Institute assesses a supplier dossier. The rubric scores documentary and analytical practice; it does not score product quality, and the draft was released for comment principally because respondents…
10 submissions2 not accepted -
Consultation on the draft of the Institute's first analytical standard, which specifies the performance a chromatographic purity determination must achieve and states, without qualification, that the resulting figure is a relative…
5 submissions2 not accepted -
Consultation on the policy governing the declaration and management of interests across the Institute, covering assessment committee members, external reviewers, contributors and respondents to consultations. The draft proceeds from the…
12 submissions3 not accepted -
Consultation on the policy governing what funding the Institute accepts, from whom, and on what published terms. The draft prohibits any funding arrangement that confers rights of review over an assessment before publication, and requires…
10 submissions3 not accepted
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