Blog
RSS FeedPosted by Michael Wonder on 08 Mar 2023
The unique device identifier: a unique opportunity
7 March 2023 - A unique device identifier is an individualised alphanumeric signature associated with a single medical device. Since 2013, ...
Posted by Michael Wonder on 03 Mar 2023
Bipartisan senators introduce bill to close pharma competition loophole
1 March 2023 - Senators Maggie Hassan and Mike Braun on Wednesday reintroduced legislation intended to close a loophole that ...
Posted by Michael Wonder on 02 Mar 2023
FDA and FTC collaborate to advance competition in the biologic marketplace
2 March 2023 - In 2021 alone, the US spent $256 billion on biologics. Although biologics comprise approximately 3% of prescriptions ...
Posted by Michael Wonder on 01 Mar 2023
A review of patient reported outcome considerations in Oncologic Drugs Advisory Committee meetings (2016-2021)
28 February 2023 - The purpose of this project was to gain insight into the role of patient reported outcome data ...
Posted by Michael Wonder on 27 Feb 2023
For Cytokinetics, an FDA rejection of its heart drug would help, not hinder
27 February 2023 - Cytokinetics was founded 26 years ago but has not yet developed a drug successfully to approval. ...
Posted by Michael Wonder on 25 Feb 2023
AI developers battle with FDA, what’s next with Amazon and One Medical, & protecting wearables data
23 February 2023 - Health tech companies are in a tizzy. After years of letting companies roll out software tools to ...
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 21 Feb 2023
The FDA returns to its bad habits
20 February 2023 - The agency may nix a new treatment for a debilitating orphan disease. ...
Posted by Michael Wonder on 20 Feb 2023
Azafaros receives additional regulatory designations for AZ-3102 from FDA, EMA and MHRA
20 February 2023 - Azafaros today announced its progress in on-going interactions with health authorities regarding its lead asset, AZ-3102. ...
Posted by Michael Wonder on 18 Feb 2023
Reata’s ‘toss up’ drug approval decision is in the unpredictable hands of FDA’s Billy Dunn
17 February 2023 - In the aftermath of the FDA’s Aduhelm debacle, the agency’s neuroscience chief Billy Dunn has another ...
Posted by Michael Wonder on 16 Feb 2023
FDA to require diversity plan for clinical trials
16 February 2023 - US regulatory agency makes ‘big change’ to increase the number of participants from under-represented groups in drug ...
Posted by Michael Wonder on 15 Feb 2023
US Government payer funded trials to address oncology's drug dosing conundrum: a Congressional call to action?
13 February 2023 - Since the mid 20th century, cancer drug development has been guided by the assumption that more is ...
Posted by Michael Wonder on 15 Feb 2023
FDA gene therapy head raises concern on accelerated approval use
14 February 2023 - More than 1,000 cell and gene therapy clinical trials registered. ...
Posted by Michael Wonder on 14 Feb 2023
The future of voice technologies in health care
13 February 2023 - Adam Smith believed that the division of labor is the key to growth. ...
Posted by Michael Wonder on 14 Feb 2023
Top FDA official interested in ‘Project Orbis’ for cell and gene therapies
13 February 2023 - A top official from the US FDA said he wants to see something similar to the agency’s ...