Blog
RSS FeedPosted 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FDA issues draft guidance: assessing registries to support regulatory decision-making for drug and biological products
29 November 2021 - Today, the U.S. FDA issued a draft guidance for industry titled "Real-World Data: Assessing Registries to Support ...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 ...
Posted by Michael Wonder on 21 Oct 2021
FDA issues draft guidance for industry on data standards for drug and biological product submissions containing real world data
21 October 2021 - Today, the U.S. FDA issued a draft guidance for industry titled Data Standards for Drug and Biological ...
Posted by Michael Wonder on 15 Oct 2021
Updates to the procedure guidance for listing medicines on the PBS
15 October 2021 - The Department has updated Section 5.8 New brand of existing pharmaceutical item submissions (not requiring PBAC consideration) ...
Posted 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 ...