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RSS FeedPosted 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 ...
Posted by Michael Wonder on 30 Dec 2022
The FDA’s ‘breakthrough’ program for medical devices keeps gaining steam
28 December 2022 - For medical devices in the Breakthrough Devices Program, 2022 has been a breakout year. ...
Posted by Michael Wonder on 29 Dec 2022
Congressional report: US FDA broke own protocols in approving Biogen Alzheimer's drug
29 December 2022 - The US FDA failed to adhere to its own guidance and internal practices during the approval ...
Posted by Michael Wonder on 27 Dec 2022
New FDA guidance explains that Plan B is not an abortion pill
23 December 2022 - The FDA on Friday altered the language attached to emergency contraceptive pills to clarify that they ...
Posted by Michael Wonder on 23 Dec 2022
FDA’s new real world evidence program offers early agency feedback
21 December 2022 - The US FDA is aiming to improve the quality of real world evidence used in regulatory ...
Posted by Michael Wonder on 21 Dec 2022
Classifying ageing as a disease could speed FDA drug approvals
21 December 2022 - The FDA considers ageing to be a natural process. This makes it difficult to get FDA approval ...
Posted by Michael Wonder on 18 Dec 2022
Ardelyx provides update on FDA appeal for Xphozah (tenapanor) for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis
16 December 2022 - Ardelyx provided an update regarding the appeal to the complete response letter for the new drug ...
Posted by Michael Wonder on 11 Dec 2022
The FDA struggle to withdraw Makena; problems with the accelerated approval process
8 December 2022 - Hydroxyprogesterone caproate (Makena) is an injectable drug for the prevention of preterm birth, ie, birth prior to ...
Posted by Michael Wonder on 10 Dec 2022
Pre-approval promises to voluntarily withdraw FDA approved drugs
9 December 2022 - The US FDA faces a persistent tension between confidence and speed. ...
Posted by Michael Wonder on 10 Dec 2022
You're cured till you're not: should disease-free survival be used as a regulatory or clinical endpoint for adjuvant therapy of cancer?
9 December 2022 - Recent commentary reviewing the use of biologics or other novel molecules tested in the adjuvant setting for ...
Posted by Michael Wonder on 04 Dec 2022
Statistical approaches to establishing bioequivalence
2 December 2022 - Requirements for submitting bioavailability and bioequivalence data in investigational new drugs, new drug applications, abbreviated new drug ...