Blog
RSS FeedPosted by Michael Wonder on 27 Mar 2023
Clinical trial considerations to support accelerated approval of oncology therapeutics
24 March 2023 - The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious ...
Posted by Michael Wonder on 27 Mar 2023
FDA outlines plan for digital health technologies for clinical trials
24 March 2023 - The US FDA plans to hold at least one public meeting and release several guidances on digital ...
Posted by Michael Wonder on 08 Feb 2023
Stakeholders want more clarity on FDA's statistical approach to assessing bioequivalence
7 February 2023 - Commenters on the US FDA draft guidance outlining principles for in vivo or in vitro bioequivalence ...
Posted by Michael Wonder on 26 Jan 2023
Draft methods (version 7.0): IQWiG is extending the comment period
26 January 2023 - The new deadline is 28 February 2023. ...
Posted by Michael Wonder on 24 Jan 2023
HAS updates its recommendations for the proper use of osteoporosis drugs
24 January 2023 - Osteoporosis is a disease whose first cause is ageing and which is characterised by the reduction ...
Posted by Michael Wonder on 19 Dec 2022
Draft guidance document on the collection and analysis of disaggregated data in clinical trials: transparency
16 December 2022 - This guidance will help sponsors interpret amendments to the Food and Drug Regulations (regulations) requiring them ...
Posted by Michael Wonder on 19 Dec 2022
Facilitating decentralised clinical trials in the EU
19 December 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published recommendations that aim to ...
Posted by Michael Wonder on 08 Dec 2022
IQWiG updates its General Methods
6 December 2022 - Revision of the cost-benefit assessment and addition of the concept of application-accompanying data collection: Comments on ...
Posted by Michael Wonder on 11 Nov 2022
CADTH launches consultation on real world evidence reporting guidance
10 November 2022 - Today, CADTH, on behalf of the Real World Evidence Steering Committee, launched a public consultation to ...
Posted by Michael Wonder on 05 Nov 2022
FDA finalises umbrella trial guidance for cell and gene therapies
4 November 2022 - The US FDA laid out its recommendations for sponsors to study multiple versions of a cellular or ...
Posted by Michael Wonder on 21 Oct 2022
FDA finalises multiple endpoints guidance
20 October 2022 - The US FDA on Thursday finalised guidance to sponsors on managing multiple outcomes in clinical trials ...
Posted by Michael Wonder on 18 Oct 2022
Tissue agnostic drug development in oncology
17 October 2022 - This guidance provides recommendations to sponsors regarding considerations for tissue agnostic drug development in oncology. ...
Posted by Michael Wonder on 29 Sep 2022
EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products
29 September 2022 - EMA is launching a pilot to support the translation of basic research developments into medicines that could ...
Posted by Michael Wonder on 08 Sep 2022
Submitting documents using real world data and real world evidence to FDA for drug and biological products
8 September 2022 - To facilitate FDA’s internal tracking of submissions to the Agency that include real world data and real ...
Posted by Michael Wonder on 22 Aug 2022
New handbook on health economic assessments of medical devices
18 August 2022 - TLV carries out health economic assessments of medical technology products at the request of the Medical Technology ...