Blog
RSS FeedPosted 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 16 Feb 2023
Human medicines: highlights of 2022
16 February 2023 - In 2022, EMA recommended 89 medicines for marketing authorisation. Of these, 411 had a new active substance ...
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7 February 2023 - Commenters on the US FDA draft guidance outlining principles for in vivo or in vitro bioequivalence ...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 06 Feb 2023
Actions to support the development of medicines for children
6 February 2023 - Regulators in the European Union have taken several initiatives in the past four years to increase the ...
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 02 Feb 2023
Professor John Skerritt retirement
2 February 2023 - Today, Professor John Skerritt has announced his decision to retire from his position of Deputy Secretary ...
Posted by Michael Wonder on 01 Feb 2023
Changes applying to evaluation of new substances for listed medicines
1 February 2023 - The TGA has introduced Mandatory requirements for applications to vary the Permissible Ingredients Determination under section 26BD ...
Posted by Michael Wonder on 01 Feb 2023
Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU
31 January 2023 - From 31 January 2023, all initial clinical trial applications in the European Union must be submitted via ...