Draft monograph: Teduglutide
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 that rating in…
§1Consultation and window
§1.1Window
- Opened
- 25 January 2024
- Closed
- 24 February 2024
- Duration
- 30 days
- Status
- Closed — the disposition is published
- Document under consultation
- Monograph: Teduglutide
- Submissions received
- 7
§1.2Consultation questions
The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.
- Is the moderate certainty rating for the principal assessed outcome correctly drawn from the contributing evidence?
- Are the evidence gaps recorded in section 9 complete, and is any material gap omitted?
- Is the analytical section proportionate to what a reader would need in order to interpret a certificate for this compound?
§1.3How a submission is handled
- Every submission is signed. The Institute publishes no anonymous submission.
- Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
- A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
- Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
- There is no voting, no reputation score, no reply thread and no editing after receipt.
§1.4Outcome
Amendments arising from the consultation were applied before ratification and are recorded in the monograph's amendment log. Each amendment is traceable to a numbered submission on the disposition page.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.