Blog
RSS FeedPosted by Michael Wonder on 29 Sep 2021
Benefit-risk assessment for new drug and biological products
29 September 2021 - The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about ...
Posted by Michael Wonder on 24 Aug 2021
Method paper: IQWiG puts draft version 6.1 up for discussion
23 August 2021 - The IQWiG has presented the draft for the next version of its General Methods. ...
Posted by Michael Wonder on 10 Aug 2021
Final guidance on metastasis-free survival in non-metastatic castration resistant prostate cancer released by the FDA
10 August 2021 - The FDA announced its finalised guidance on the use of metastases-free survival as an outcome for ...
Posted by Michael Wonder on 06 Aug 2021
Updated financial estimates workbook
6 August 2021 - An updated version of the Utilisation and Cost Model workbook is now available to support PBAC submissions. ...
Posted by Michael Wonder on 04 Aug 2021
Collecting patient reported outcomes in cancer clinical trials
3 August 2021 - To help patients with cancer learn more about how treatment may affect their quality of life, the ...
Posted by Michael Wonder on 22 Jun 2021
Update of handbook for companies applying for a subsidy
18 June 2021 - The Swedish Dental and Pharmaceutical Benefits Agency, TLV, has updated parts of the handbook for companies ...
Posted by Michael Wonder on 16 Jun 2021
MSAC consultation process - changes to take effect from 1 July 2021
16 June 2021 - MSAC is implementing changes to its consultation process from 1 July 2021. ...
Posted 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, ...