Blog
RSS FeedPosted by Michael Wonder on 25 May 2022
Review of discount rate in the PBAC Guidelines
25 May 2022 - The Commonwealth has entered into a new Strategic Agreement in relation to reimbursement, health technology assessment ...
Posted by Michael Wonder on 24 May 2022
EMA guidance supports development of new antibiotics
24 May 2022 - As part of its efforts to support a global approach to the development of new antimicrobial medicines, ...
Posted by Michael Wonder on 04 May 2022
Methods paper: new version 6.1 becomes effective – English translation now available
2 May 2022 - The amendments concern, among other things, the approach to evidence searches for clinical practice guidelines. New ...
Posted by Michael Wonder on 05 Apr 2022
Consultation now open - review of base case discount rate at 3A.1 of the PBAC Guidelines
5 April 2022 - The Commonwealth has entered into a new Strategic Agreement in relation to reimbursement, health technology assessment ...
Posted by Michael Wonder on 25 Mar 2022
Updated procedures and guidelines for company submissions to ACE
25 March 2022 - Version 1.1 of ACE's "Procedures and guidelines for company submissions to the Agency for Care Effectiveness for ...
Posted by Michael Wonder on 16 Mar 2022
FDA drafts guidance on genome editing, CAR T cell therapies
16 March 2022 - The U.S. FDA has issued two draft guidances addressing the development of human gene therapy products that ...
Posted by Michael Wonder on 02 Mar 2022
Assessing unexpected circumstances that lead to modifications in clinical trial design, conduct, or analysis application of the CONSERVE Reporting Guideline
1 March 2022 - In the COVID-19 Dexamethasone (CoDEX) randomised clinical trial, which studied a sample of critically ill patients with ...
Posted by Michael Wonder on 31 Jan 2022
NICE publishes new combined methods and processes manual and topic selection manual for its health technology evaluation programmes
31 January 2022 - Changes to the way medicines and other health technologies are evaluated by NICE have now been incorporated ...
Posted by Michael Wonder on 24 Jan 2022
Method paper: new version 6.1 comes into force
24 January 2022 - The innovations concern, among other things, the procedure for evidence searches for medical guidelines. New concept ...
Posted by Michael Wonder on 14 Jan 2022
Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations
11 January 2022 - The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. ...
Posted by Michael Wonder on 16 Dec 2021
NICE recommends offering PrEP to people at high risk of HIV for first time
15 December 2021 - People at the highest risk of catching HIV should be offered pre-exposure prophylaxis, NICE has recommended for ...
Posted by Michael Wonder on 14 Dec 2021
FDA publishes discussion paper and seeks public input on 3D printing of medical devices at the point of care
10 December 2021 - Today, the U.S. FDA published a discussion paper regarding 3D printing medical devices at the point of ...
Posted by Michael Wonder on 29 Nov 2021
FDA issues draft guidance: assessing registries to support regulatory decision-making for drug and biological products
29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support ...
Posted by Michael Wonder on 27 Nov 2021
Can we trust strong recommendations based on low quality evidence?
25 November 2021 - A necessary requirement for development of trustworthy guidelines is to respect the relation between the quality (certainty) ...
Posted by Michael Wonder on 26 Oct 2021
Strengthening the reporting of observational studies in epidemiology using Mendelian randomisation: the STROBE-MR Statement
26 October 2021 - An international expert committee, informed by the methodological framework for guideline development of the Enhancing the Quality ...