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 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 ...
Posted by Michael Wonder on 13 Feb 2023
Assessment of FDA approved drugs not recommended for use or reimbursement in other countries (2017-2020)
13 February 2023 - In this cross-sectional study of all 206 new US drug approvals in 2017 through 2020, 47 drugs ...
Posted by Michael Wonder on 13 Feb 2023
US FDA approval of drugs not meeting pivotal trial primary outcomes (2018-2021)
13 February 2023 - In June 2021, the US FDA granted accelerated approval to aducanumab for the treatment of Alzheimer disease ...
Posted by Michael Wonder on 11 Feb 2023
Republicans back lawsuit to overturn FDA approval of abortion pill and pull the medication from US market
10 February 2023 - 22 Republican attorneys general and 67 GOP members of Congress backed a suit seeking to overturn FDA ...
Posted by Michael Wonder on 08 Feb 2023
Stakeholders want more clarity on FDA's statistical approach to assessing bioequivalence
7 February 2023 - Commenters on the US FDA draft guidance outlining principles for in vivo or in vitro bioequivalence ...
Posted by Michael Wonder on 03 Feb 2023
Medicare may test policy of paying less for accelerated approval drugs
31 January 2023 - Medicare official hinted Tuesday that Medicare might test a policy of paying less for drugs that ...
Posted by Michael Wonder on 31 Jan 2023
Association between pre-approval confirmatory trial initiation and conversion to traditional approval or withdrawal in the FDA accelerated approval pathway
27 January 2023 - The accelerated approval pathway allows the US FDA to approve drugs that demonstrate an effect on a ...