Blog
RSS FeedPosted by Michael Wonder on 13 Feb 2024
The threat of fungal infections is growing. Why is it so hard to make new drugs?
11 February 2024 - Last summer, the FDA denied an application for a new anti-fungal drug called olorofim, sending it back ...
Posted by Michael Wonder on 07 Feb 2024
FDA and EMA launch parallel scientific advice pilot program for complex generics
7 February 2024 - CDER’s Office of Generic Drugs and the EMA launched a voluntary pilot program to facilitate concurrent discussions ...
Posted by Michael Wonder on 04 Feb 2024
Addressing the challenge of common chronic diseases — a view from the FDA
3 February 2024 - Of the 10 most common causes of death in the United States, 7 are chronic diseases: ...
Posted by Michael Wonder on 29 Sep 2023
FDA launches pilot program to help further accelerate development of rare disease therapies
29 September 2023 - Today, the US FDA is taking steps to help further accelerate the development of novel drug and ...
Posted by Michael Wonder on 23 Jul 2023
How a drug maker profited by slow walking a promising HIV therapy
22 July 2023 - Gilead delayed a new version of a drug, allowing it to extend the patent life of a ...
Posted by Michael Wonder on 07 Jul 2023
A priority review voucher program to fuel generic drug development
6 July 2023 - Millions of Americans report that they are unable to fill their prescriptions or are not taking their ...
Posted by Michael Wonder on 06 Jun 2023
FDA announces additional steps to modernise clinical trials
6 June 2023 - Agency requesting feedback on the draft recommendations and how they should be applied to increasingly diverse trial ...
Posted by Michael Wonder on 22 Mar 2023
Drug repurposing during the COVID-19 pandemic: lessons for expediting drug development and access
20 March 2023 - The COVID-19 pandemic created a large, sudden unmet public health need for rapid access to safe and ...
Posted 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. ...