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RSS FeedPosted by Michael Wonder on 20 Feb 2023
EMA publishes agenda for 20-23 February 2023 CHMP meeting
20 February 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 23 Jan 2023
EMA publishes agenda for 23-26 January 2023 CHMP meeting
23 January 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 13 Dec 2022
EMA publishes agenda for the 12-15 December CHMP meeting
12 December 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 11 Oct 2022
EMA publishes minutes of bilateral EMA – EUnetHTA meeting (June 2022)
11 October 2022 - The chairs welcome participants to the first bilateral under the new Work Plan between EUnetHTA 21 ...
Posted by Michael Wonder on 10 Oct 2022
EMA publishes agenda for 10-13 October 2022 CHMP meeting
10 October 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 14 Sep 2022
Independent review of paracetamol overdose
14 September 2022 - The TGA has published an independent expert report examining the incidence of serious injury and death ...
Posted by Michael Wonder on 12 Sep 2022
EMA publishes agenda for 12-15 September 2022 CHMP meeting
12 September 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 16 Aug 2022
EMA publishes agenda for 16-19 August CHMP meeting
16 August 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 21 Jul 2022
FDA offers new guidance on therapeutic equivalence evaluations
20 July 2022 - In draft guidance issued on Wednesday, the US FDA explains its approach to therapeutic equivalence evaluations and ...
Posted by Michael Wonder on 19 Jul 2022
EMA publishes agenda for 18-21 July 2022 CHMP meeting
18 July 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 07 Jul 2022
EMA finalises companion diagnostic guidance
7 July 2022 - The EMA) has finalised guidance on companion diagnostics, addressing procedural aspects to facilitate consultation between EMA ...