Blog
RSS FeedPosted by Michael Wonder on 09 Feb 2023
Biden to push for insulin cost caps, but unlikely to secure Congressional approval
8 February 2023 - US President Joe Biden will call for a nationwide cap of $35 a month on out ...
Posted by Michael Wonder on 08 Feb 2023
Novartis CEO Narasimhan suggests possible legislative action to reverse Inflation Reduction Act’s impact on drug prices: what can and can’t be done
7 February 2023 - It’s no secret that the pharmaceutical industry aims to blunt the Inflation Reduction Act’s effects, specifically ...
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7 February 2023 - Commenters on the US FDA draft guidance outlining principles for in vivo or in vitro bioequivalence ...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 07 Feb 2023
The EU butts heads with big pharma to make medicines cheaper
2 February 2023 - The bloc’s pharma reform aims to get new drugs to patients faster, for less money. But it ...
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
A prescription drug affordability board would lower prescription costs
1 February 2023 - Del. Rasoul is proposing Virginia create an independent panel of health care experts to review drug price ...
Posted by Michael Wonder on 02 Feb 2023
Drug prices increase 5.6% as Government ramps up pressure to lower costs
2 February 2023 - Restrained increases come as US implements the Inflation Reduction Act. ...
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
ABPI response to new MHRA fees announced for 1 April 2023
1 February 2023 - These fee increases are an important step to ensuring the MHRA has the resources it needs ...
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 ...
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 ...
Posted by Michael Wonder on 31 Jan 2023
FDA may not always require post-approval trials to be enrolled before accelerated approvals
30 January 2023 - A FDa official on Monday gave more clues for how the agency plans to wield new authority ...
Posted by Michael Wonder on 31 Jan 2023
Medicare drug price negotiation in the United States: implications and unanswered questions
8 December 2022 - The United States is a relatively free pricing market for pharmaceutical manufacturers to set list prices at ...