Newsletter - May 11, 2023
COVID Emergency Officially Ends Today but Not EUAs: FDA
As of today, 11 May 2023, the Public Health Emergency (PHE) for COVID-19 declared in January 2020 expired but this would not affect the various products authorized for Covid via Emergency Use Authorization (EUA). This is because under US laws, the PHE and the EUA are not linked. PHE refers to specific...Read More
FDA Discusses Regulatory Concerns for Use of AI in Drug Development
The last 5 years have seen extensive use of artificial intelligence (AI) algorithms for drug and medical device development. Till earlier this year, the regulatory discussions about AI were focused on medical devices but now FDA has released two white papers of use of this technology for the drugs and biologics...Read More
COVID Emergency Officially Ends Today but Not EUAs: FDA
As of today, 11 May 2023, the Public Health Emergency (PHE) for COVID-19 declared in January 2020 expired but this would not affect the various products authorized for Covid via Emergency Use Authorization (EUA). This is because under US laws, the PHE and the EUA are not linked. PHE refers to specific...Read More
FDA Discusses Regulatory Concerns for Use of AI in Drug Development
The last 5 years have seen extensive use of artificial intelligence (AI) algorithms for drug and medical device development. Till earlier this year, the regulatory discussions about AI were focused on medical devices but now FDA has released two white papers of use of this technology for the drugs and biologics...Read More
