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RSS FeedPosted by Michael Wonder on 15 Jun 2023
FDA should reject accelerated approval of gene therapy SRP-9001
15 June 2023 - The US FDA should reject the accelerated approval of the gene therapy SRP-9001 (Sarepta Therapeutics) for ...
Posted by Michael Wonder on 16 May 2023
The decline of science at the FDA has become unmanageable
15 May 2023 - Before 1962, US federal law did not require pre-marketing proof of effectiveness for drugs. But senate hearings ...
Posted by Michael Wonder on 15 May 2023
Drug companies are minting billions on unproven treatments with FDA shortcut
15 May 2023 - Accelerated approvals have helped get promising therapies to market fast — but follow-up research to confirm that ...
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Health care regulators’ outdated thinking will cost American ives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 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FDA draft guidance allows AI/ML devices to evolve without requiring new submissions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 21 Mar 2023
Top FDA official: agency needs to start using accelerated approval for gene therapies
20 March 2023 - A top FDA official said Monday that the agency needs to start using accelerated approval, a ...
Posted by Michael Wonder on 20 Mar 2023
Opioid settlement hinders patients’ access to a wide array of drugs
13 March 2023 - An agreement between attorneys general and major drug distributors increased scrutiny on medications for ADHD, addiction, anxiety ...