Blog
RSS FeedPosted 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7 February 2023 - Commenters on the US FDA draft guidance outlining principles for in vivo or in vitro bioequivalence ...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 ...
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 ...
Posted by Michael Wonder on 26 Jan 2023
Update on US FDA emergency use authorisation of Evusheld
26 January 2023 - The US FDA has stated that AstraZeneca’s Evusheld (tixagevimab and cilgavimab) is not currently authorised for ...
Posted by Michael Wonder on 26 Jan 2023
Patent reform and lower drug prices should be bipartisan priorities
25 January 2023 - As the 118th Congress convenes this month in Washington D.C., many pundits and advocates have little ...
Posted by Michael Wonder on 26 Jan 2023
A “method of use” to prevent generic and biosimilar market entry
25 January 2023 - A critical pathway that generics and biosimilars manufacturers have used to circumvent patent thickets has been “skinny ...
Posted by Michael Wonder on 24 Jan 2023
The FDA’s power to approve drugs faces sweeping challenge in lawsuit seeking to pull abortion pill from US market
24 January 2023 - Anti-abortion physicians are suing to overturn the FDA’s approval of mifepristone, which dates back more than two ...
Posted by Michael Wonder on 23 Jan 2023
Despite court ruling, FDA will continue with its approach to approving orphan drug exclusivity
23 January 2023 - In an unexpected move, the FDA will continue to apply exclusive marketing rights for so called ...
Posted by Michael Wonder on 18 Jan 2023
FDA’s breakthrough program: faster drug OKs without sacrificing safety
18 January 2023 - A FDA program markedly cut the time and cost of bringing to market new drugs, without ...
Posted by Michael Wonder on 13 Jan 2023
Recent patent reform bills and their implications for prescription drugs
13 January 2022 - In 2022, several bills were introduced in Congress to revamp US intellectual property law. ...
Posted by Michael Wonder on 10 Jan 2023
Four types of bias in medical AI are running under the FDA’s radar
9 January 2023 - Although artificial intelligence is entering health care with great promise, clinical artificial intelligence tools are prone ...