Blog
RSS FeedPosted 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 24 Mar 2022
Pressured by patients, FDA reviews ALS drug with modest data
25 March 2022 - The FDA meets next week to review a closely watched drug for ALS, or Lou Gehrig’s ...
Posted 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 24 Jun 2021
ALS association wants more commitment from the FDA
24 June 2021 - In a response letter to the ALS Association, the U.S. FDA has recognised the unmet therapeutic ...
Posted by Michael Wonder on 11 May 2021
The pharma industry needs to measure patient experience from the patients’ perspectives
10 May 2021 - The relationship between clinical outcomes and the patient experience — the sum of all of interactions ...
Posted by Michael Wonder on 22 Feb 2021
EMA plots earlier engagement with patient groups
19 February 2021 - The EMA on Friday announced it will pilot an early engagement program to bring patient and ...
Posted by Michael Wonder on 15 Oct 2020
EMA cancer symposium: new approaches in patient-focused cancer medicine development
15 October 2020 - On Thursday, 29 October, EMA is hosting a symposium to discuss new approaches to facilitating and ...
Posted by Michael Wonder on 04 Jun 2020
Patients’ and health care professionals’ organisations updated on EMA’s response to COVID-19
4 June 2020 - EMA updated patients’ and healthcare professionals’ organisations about its COVID-19 activities. ...
Posted by Michael Wonder on 29 Jan 2020
The FDA wants to know how Instagram influencers sway patient views on medicines
28 January 2020 - In 2015, Kim Kardashian promoted a morning-sickness pill to her millions of followers on social media, ...
Posted by Michael Wonder on 02 Dec 2019
Engaging patients in medicines regulation: a tale of two agencies
2 December 2019 - The EMA and the US FDA have committed to engaging patients in their regulatory processes to promote ...
Posted by Michael Wonder on 10 Nov 2019
Patient perspective is vital to FDA's work
7 November 2019 - As an oncologist, I was eager to come work at the U.S. FDA, where I knew ...
Posted by Michael Wonder on 23 Sep 2019
Statement on FDA efforts to encourage patient engagement in medical device clinical investigations
23 September 2019 - At the U.S. FDA we are committed to keeping patients, their families and caregivers at the center ...
Posted by Michael Wonder on 24 Jun 2019
Incorporating patient preferences in non-inferiority trials
24 June 2019 - Non-inferiority trials imply a trade-off between a loss in efficacy of a standard treatment in exchange for ...
Posted by Michael Wonder on 27 Feb 2019
Patient experience data and bias — what ratings don’t tell us
28 February 2018 - Although patient-experience data are important to U.S. health care organisations, the best way to interpret them remains ...
Posted by Michael Wonder on 26 Feb 2019
The FDA's Oncology Center of Excellence — quantifying the patient experience
23 February 2019 - Cancer therapies are typically evaluated based on their ability to control the growth of a tumor ...