Blog
RSS FeedPosted by Michael Wonder on 23 Apr 2023
EMA addresses considerations for single-arm trials
21 April 2023 - A new reflection paper from the EMA offers some suggestions to sponsors on how to design ...
Posted by Michael Wonder on 22 Apr 2023
Mifepristone: US Supreme Court preserves abortion drug access
22 April 2023 - The US Supreme Court has preserved access to a commonly used abortion pill, ruling the drug ...
Posted by Michael Wonder on 20 Apr 2023
FDA approval processes for therapeutic drugs must be improved
18 April 2023 - The FDA’s glacial pace at reviewing and approving new drugs has an enormous opportunity cost for ...
Posted by Michael Wonder on 13 Apr 2023
Blocking FDA approval of abortion pill could stifle innovation in the biopharma industry, experts say
13 April 2023 - If courts affirm US District Judge Matthew Kacsmaryk’s decision to suspend the FDA’s approval, it could make ...
Posted by Michael Wonder on 11 Apr 2023
Abortion ruling could undermine the FDA’s drug approval authority
10 April 2023 - Legal scholars say the ruling by a Texas judge, if upheld, could spur disputes over many medications ...
Posted by Michael Wonder on 10 Apr 2023
Health care regulators’ outdated thinking will cost American ives
10 April 2023 - In a matter of months, ChatGPT has radically altered our nation’s views on artificial intelligence—uprooting old ...
Posted by Michael Wonder on 08 Apr 2023
Federal judge stays FDA abortion pill approval, gives Biden administration time to appeal
7 April 2023 - A federal judge in Texas on Friday stayed the FDA’s approval of the abortion pill mifepristone, ...
Posted by Michael Wonder on 07 Apr 2023
FDA Commissioner and Chief Scientist announce decision to withdraw approval of Makena
6 April 2023 - Today, the US FDA announced the final decision to withdraw approval of Makena—a drug that had been ...
Posted by Michael Wonder on 04 Apr 2023
New features further strengthen Priority Medicines scheme (PRIME)
4 April 2023 - The EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to ...
Posted by Michael Wonder on 03 Apr 2023
FDA draft guidance allows AI/ML devices to evolve without requiring new submissions
31 March 2023 - The US FDA published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) ...
Posted by Michael Wonder on 02 Apr 2023
Ensuring public trust in an empowered FDA
1 April 2023 - The FDA’s recent approval of lecanemab for Alzheimer’s disease has been clouded by controversy over other accelerated ...
Posted by Michael Wonder on 29 Mar 2023
Medical device companies now need to prove to FDA they’re protected against cyber attacks
29 March 2023 - Hidden in this year’s federal spending bill, among major changes to Medicare payments to doctors and ...
Posted by Michael Wonder on 28 Mar 2023
DARWIN EU has completed its first studies and is calling for new data partners
28 March 2023 - DARWIN EU, the Data Analysis and Real World Interrogation Network, has accomplished its first year of establishment. ...
Posted by Michael Wonder on 27 Mar 2023
TGA’s new powers will help reduce the impact of medicine shortages on patients
24 March 2023 - From 22 March 2023, the TGA can approve the temporary import or supply of an overseas approved ...
Posted by Michael Wonder on 22 Mar 2023
Advancing regulatory science in the EU – mid-point report published
22 March 2023 - The EMA has published a report summarising the mid-term achievements of its regulatory science strategy to ...