Blog
RSS FeedPosted by Michael Wonder on 23 Feb 2023
FDA continues important work to advance medical products for patients with rare diseases
23 February 2023 - Patients with rare diseases are experts in their health condition. They provide a unique perspective, and ...
Posted by Michael Wonder on 11 Jan 2023
CDER director calls for simplifying clinical trials to boost diversity
10 January 2023 - Encouraging researchers and sponsors to simplify clinical trials and employ a fit for purpose protocol is ...
Posted by Michael Wonder on 07 Dec 2022
An innovation surcharge to fund the repurposing of generic drugs
10 November 2022 - The use of generic drugs continues to increase, generating substantial savings for purchasers and improving affordable access ...
Posted by Michael Wonder on 27 Oct 2022
FDA continues to advance medicines for children
27 October 2022 - Increasing the availability of safe and effective medicines for children is a key priority for the US ...
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 07 Oct 2022
The critical role of academic clinical trials in paediatric cancer drug approvals: design, conduct, and fit for purpose data for positive regulatory decisions
6 October 2022 - For decades, academic clinical trials consortia have collaborated to optimise outcomes for childhood cancers through evaluating incremental ...
Posted by Michael Wonder on 14 Sep 2022
Improving dose optimisation processes used in oncology drug development to minimise toxicity and maximise benefit to patients
12 September 2022 - We reviewed US FDA initial approvals (2019-2021) of small molecules and antibody-drug conjugates for oncologic indications. ...
Posted by Michael Wonder on 22 Aug 2022
Three imperatives for R&D in biosimilars
19 August 2022 - The biosimilars market is poised to grow over the next decade. ...
Posted by Michael Wonder on 02 Aug 2022
FDA official: patients play an increasing role in rare disease drug development
1 August 2022 - Patients have a critical role in drug development, from identifying unmet medical needs to assessing meaningful ...
Posted by Michael Wonder on 01 Aug 2022
Advancing innovative clinical trials to efficiently deliver medicines to patients
1 August 2022 - Complex innovative designs in clinical trials have the potential to increase efficiency and lower the cost of ...
Posted by Michael Wonder on 26 Jul 2022
‘No magic bullet’: For drug makers and the FDA, clinical trials on ultra rare diseases pose thorny challenges
26 July 2022 - Walker Burger is beside himself with worry. ...
Posted by Michael Wonder on 14 Jun 2022
FDA’s treatment of China developed drugs spurs demands for multiregional clinical trials
14 June 2022 - China’s ambition to become a leader in the biopharma industry has been clear in the last ...
Posted by Michael Wonder on 12 May 2022
Basket trials: review of current practice and innovations for future trials
10 May 2022 - Basket trials, one type of master protocol, emerged as a tool for evaluating biomarker-targeted therapies among multiple ...
Posted by Michael Wonder on 10 May 2022
FDA launches new Accelerating Rare disease Cures (ARC) program
10 May 2022 - FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce the launch of the new ...
Posted by Michael Wonder on 09 Feb 2022
FDA raises concerns about China developed drugs
9 February 2022 - Agency could slow the plans of big Western drugmakers to sell Chinese tested medicines in U.S. ...