Blog
RSS FeedPosted by Michael Wonder on 20 Aug 2022
Regulatory considerations to keep pace with innovation in digital health products
19 August 2022 - Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital ...
Posted by Michael Wonder on 21 Jul 2022
FDA offers new guidance on therapeutic equivalence evaluations
20 July 2022 - In draft guidance issued on Wednesday, the US FDA explains its approach to therapeutic equivalence evaluations and ...
Posted by Michael Wonder on 07 Jul 2022
EMA finalises companion diagnostic guidance
7 July 2022 - The EMA) has finalised guidance on companion diagnostics, addressing procedural aspects to facilitate consultation between EMA ...
Posted by Michael Wonder on 07 Jun 2022
Global expert panel publishes guidance on deliberative processes for health technology assessment
7 June 2022 - Value in Health announced today the publication of guidance regarding the establishment or improvement of deliberative ...
Posted by Michael Wonder on 30 May 2022
NICE sets out further details on menopause guideline update
27 May 2022 - NICE has outlined what aspects of menopause care will be updated in upcoming guidance, including areas where ...
Posted 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. ...