Blog
RSS FeedPosted 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2 February 2021 - The European Medicines Agency has released a draft guidance to assist drug developers using its Priority ...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. ...
Posted by Michael Wonder on 07 Oct 2020
FDA issues guidance on Emergency Use Authorisation for COVID-19 vaccines
6 October 2020 - Today, the U.S. FDA issued guidance with recommendations for vaccine sponsors regarding the scientific data and ...
Posted by Michael Wonder on 02 Oct 2020
Biotech industry pushes Trump Administration to release new vaccine guidelines
2 October 2020 - The BIO trade group, whose members include most of the vaccine makers, asked the health secretary to ...
Posted by Michael Wonder on 17 Sep 2020
EMA close to finalising guidance for advanced therapies
16 September 2020 - The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal ...
Posted by Michael Wonder on 31 Aug 2020
FDA releases draft guidance on PROs for device manufacturers
31 August 2020 - Device manufacturers have new draft guidance from the US FDA for the selection of patient-reported outcome ...
Posted by Michael Wonder on 31 Aug 2020
Consultation on the Medical Services Advisory Committee revised draft guidelines
31 August 2020 - The Department of Health is interested in obtaining views and feedback from the general public and ...
Posted by Michael Wonder on 27 Aug 2020
FDA works to evaluate cancer therapies in patients with brain metastases
27 August 2020 - Today, the U.S. FDA issued a draft guidance document, “Evaluating Cancer Drugs in Patients with Central Nervous ...