Blog
RSS FeedPosted by Michael Wonder on 25 Jul 2021
Patient advocacy organisations and FDA drug approval: lessons from Aduhelm
23 July 2021 - In the wake of last month’s controversial FDA approval of Biogen’s Aduhelm, Alzheimer’s Association CEO Harry ...
Posted by Michael Wonder on 19 Jul 2021
Making sense of the FDA’s ‘indefensible’ decision to approve Aduhelm
19 July 2021 - There are three sides to every story that defies logic: the defenders’ side, the critics’ side and ...
Posted by Michael Wonder on 19 Jul 2021
Lilly and Incyte provide update on supplemental new drug application for baricitinib for the treatment of moderate to severe atopic dermatitis
16 July 2021 - Eli Lilly and Incyte announced today that the U.S. FDA will not meet the Prescription Drug User ...
Posted by Michael Wonder on 19 Jul 2021
AbbVie provides update regarding Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in the U.S.
16 July 2021 - AbbVie today announced the U.S. FDA did not meet the Prescription Drug User Fee Act action ...
Posted by Michael Wonder on 10 Jul 2021
FDA seeks to probe talks between staff and Biogen on Alzheimer’s drug
9 July 2021 - The FDA’s chief is taking the highly unusual step of asking for a federal investigation of doctors ...
Posted by Michael Wonder on 12 Jan 2021
STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies
12 January 2021 - In alignment with the International Council of Harmonization’s strategic goals, a public private consortium has developed a ...
Posted by Michael Wonder on 04 Dec 2020
ICER opens nominations for new members of its voting panels
2 December 2020 - Independent panel members debate the evidence on the effectiveness and value of new drugs and other ...
Posted by Michael Wonder on 11 Aug 2020
FDA head pledges 'we will not cut corners' on coronavirus vaccine
10 August 2020 - The head of the FDA pledged Monday that the U.S. "will not cut corners" in its ...
Posted by Michael Wonder on 06 Aug 2020
Health experts to FDA: make your vaccine deliberations public
5 August 2020 - A letter signed by nearly 400 health experts asked the agency to use its vaccine advisory panel ...
Posted by Michael Wonder on 16 Jun 2020
Advancing structured decision‐making in drug regulation at the FDA and EMA
11 June 2020 - FDA’s recent benefit‐risk framework was developed for improving the clarity and consistency in communicating the reasoning behind ...
Posted by Michael Wonder on 15 May 2020
International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials
15 May 2020 - Regulators are highlighting the need for a comprehensive international coordination mechanism to allow the conduct of ...
Posted by Michael Wonder on 14 Jan 2020
FDA approves drugs faster than ever but relies on weaker evidence, researchers find
14 January 2020 - The FDA has gotten faster at approving new prescription drugs over the past four decades, but ...
Posted by Michael Wonder on 02 Oct 2019
How to ensure that novel analytic methods are fit for decision-making
2 October 2019 - The past decade has seen the increased generation and availability of new data sources such as ...
Posted by Michael Wonder on 12 Sep 2019
When are RCTs required for breakthrough drugs, HDEs? JAMA study investigates
11 September 2019 - A new study in JAMA Network Open finds that drugs and medical devices approved by the ...
Posted by Michael Wonder on 11 Sep 2019
The use of validated and non-validated surrogate endpoints in two EMA expedited approval pathways: A cross-sectional study of products authorised 2011–2018
10 September 2019 - In situations of unmet medical need or in the interests of public health, expedited approval pathways, ...