Blog
RSS FeedPosted by Michael Wonder on 16 Jun 2021
MSAC Technical Guidelines - release of guidelines for preparing assessments for the Medical Services Advisory Committee (Version 1.0, May 2021)
16 June 2021 - The Department of Health is pleased to announce the publication of the Guidelines for Preparing Assessments ...
Posted by Michael Wonder on 10 Jun 2021
Core patient reported outcomes in cancer clinical trials
9 June 2021 - This guidance provides recommendations to sponsors for collection of a core set of patient reported clinical outcomes ...
Posted by Michael Wonder on 26 May 2021
FDA announces draft guidances to help increase transparency, assist reporting and timely completion for certain medical device studies after FDA approval or clearance
26 May 2021 - Today, the U.S. FDA issued two guidances regarding the surveillance of certain medical devices. ...
Posted by Michael Wonder on 24 May 2021
Adjusting for covariates in randomised clinical trials for drugs and biological products
20 May 2021 - This guidance represents FDA’s current thinking on adjusting for covariates in the statistical analysis of randomised clinical ...
Posted by Michael Wonder on 13 Apr 2021
New recommendations on the critical appraisal of systematic reviews with cost and cost effectiveness outcomes
13 April 2021 - ISPOR announced today the publication of new guidance on how to evaluate the quality and risk ...
Posted by Michael Wonder on 23 Mar 2021
NICE publishes single guideline for managing COVID-19
23 March 2021 - One year on from the first national lockdown, NICE has today published a single guideline for the ...
Posted by Michael Wonder on 25 Feb 2021
Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
25 February 2021 - EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in ...
Posted by Michael Wonder on 07 Feb 2021
Modifying NICE’s approach to equity weighting
7 February 2021 - The UK’s NICE recently launched a consultation on the methods it uses to evaluate new health technologies, ...
Posted by Michael Wonder on 07 Feb 2021
NICE’s discounting review: clear thinking on rational revision meets obstacle of industrial interests
7 February 2021 - NICE recently published a review of discounting practice and theory as part of a consultation on ...
Posted by Michael Wonder on 04 Feb 2021
NICE’s processes of technology evaluation - presenting a case for change
4 February 2021 - NICE has today launched a public consultation on proposals for changes to the processes it uses to ...
Posted by Michael Wonder on 03 Feb 2021
New toolbox available for EMA's PRIME designees
2 February 2021 - The European Medicines Agency has released a draft guidance to assist drug developers using its Priority ...
Posted by Michael Wonder on 13 Dec 2020
Qualitative comparative analysis of health economic evaluation guidelines for health technology assessment in European countries
10 December 2020 - Zisis and colleagues performed a literature review to identify published guidance for the conduct and assessment ...
Posted by Michael Wonder on 11 Nov 2020
FDA offers guidance to enhance diversity in clinical trials, encourage inclusivity in medical product development
9 November 2020 - To further promote and protect public health, it is important that people who are in clinical trials ...
Posted by Michael Wonder on 06 Nov 2020
NICE’s methods of technology evaluation - presenting a case for change
6 November 2020 - NICE has today launched a public consultation on proposals for changes to the methods it uses to ...
Posted by Michael Wonder on 05 Nov 2020
IQWiG publishes a new version of its general methods
5 November 2020 - New features include the investigation of volume-outcome relationships and different mean observation times in clinical studies. ...