Blog
RSS FeedPosted by Michael Wonder on 30 Aug 2023
FDA issues final guidance on considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
30 August 2023 - Today, the US FDA issued a final guidance for industry titled Considerations for the Use of Real-World ...
Posted by Michael Wonder on 27 May 2023
Adjusting for covariates in randomized clinical trials for drugs and biological products
26 May 2023 - This final guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomised ...
Posted 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7 February 2023 - Commenters on the US FDA draft guidance outlining principles for in vivo or in vitro bioequivalence ...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 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 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 20 Aug 2022
Regulatory considerations to keep pace with innovation in digital health products
19 August 2022 - Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital ...
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 16 Mar 2022
FDA drafts guidance on genome editing, CAR T cell therapies
16 March 2022 - The U.S. FDA has issued two draft guidances addressing the development of human gene therapy products that ...
Posted by Michael Wonder on 02 Mar 2022
Assessing unexpected circumstances that lead to modifications in clinical trial design, conduct, or analysis application of the CONSERVE Reporting Guideline
1 March 2022 - In the COVID-19 Dexamethasone (CoDEX) randomised clinical trial, which studied a sample of critically ill patients with ...
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 ...