Blog
RSS FeedPosted by Michael Wonder on 20 Nov 2023
The FDA is at a crossroads on cell and gene therapies
20 November 2023 - Cell and gene therapies are the next frontier in medicine and promise long-sought hope for people ...
Posted by Michael Wonder on 16 Nov 2023
Data sharing a a new era for research funded by the US Government
15 November 2023 - In January 2023, the NIH implemented its new Data Management and Sharing Policy. ...
Posted by Michael Wonder on 15 Nov 2023
To get things done fast at FDA: ‘don’t tell anybody,’ cancer chief says
15 November 2023 - The FDA’s top cancer drug regulator doesn’t always ask for permission before taking on big initiatives. ...
Posted by Michael Wonder on 14 Nov 2023
Inequitable conduct and invalidation of patents related to FDA regulated products
13 November 2023 - Median brand name drug launch prices increased from $2,115 in 2008 to $180,007 in 2021. ...
Posted by Michael Wonder on 14 Nov 2023
Ancillary product patents to extend biologic patent life
13 November 2023 - In 2021, 46% ($260 billion) of all gross prescription drug spending in the US was on biologic ...
Posted by Michael Wonder on 09 Nov 2023
FDA’s Califf wants to get the public as excited about life expectancy as cures
8 November 2023 - It’s easy to get people worked up about cures, but they don’t seem to be bothered ...
Posted by Michael Wonder on 08 Nov 2023
FDA finalises guidance on real-time review of oncology drugs
7 November 2023 - The US FDA has finalised its guidance that outlines the eligibility and submission requirements for applicants interested ...
Posted by Michael Wonder on 04 Nov 2023
How should the FDA evaluate psychedelic medicine?
4 November 2023 - Drug companies are spending millions of dollars to incorporate psychedelic agents into health care. Working with ...
Posted by Michael Wonder on 02 Nov 2023
The FDA and Moderna’s cosy relationship: how lax rules enable a revolving door culture
1 November 2023 - After holding oversight roles for covid vaccines, two regulators from the US FDA went to work for ...
Posted by Michael Wonder on 02 Nov 2023
FDA notes “continued growth” of Orbis collaborative review program, adds EMA as observer
1 November 2023 - There has been “continued growth” in the number of applications submitted to Project Orbis, and the ...
Posted by Michael Wonder on 11 Oct 2023
FDA establishes new advisory committee on digital health technologies
11 October 2023 - Today, the US FDA announced the creation of a new Digital Health Advisory Committee to help ...
Posted by Michael Wonder on 16 Sep 2023
FDA’s final breakthrough devices guidance now includes technologies that address health disparities
15 September 2023 - Final guidance on the US FDA breakthrough device program includes new language noting that the program ...
Posted by Michael Wonder on 13 Sep 2023
FDA proposes changes to key approval pathway for medical devices, five years after promising
12 September 2023 - Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, ...
Posted by Michael Wonder on 30 Aug 2023
FDA issues final guidance on considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
30 August 2023 - Today, the US FDA issued a final guidance for industry titled Considerations for the Use of Real-World ...
Posted by Michael Wonder on 16 Aug 2023
In a rare move, FDA threatens to fine a company for failing to report clinical trial results
16 August 2023 - For only the fifth time, the FDA recently threatened to fine a company or clinical trial ...