Could Help to Streamline Development and Approval -
On May 25, 2023, the Food and Drug Administration (“FDA” or the “Agency”) announced the availability of a new Draft Guidance for Industry, Generally Accepted Scientific...more
2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over forty novel drugs and biologics and...more
1/16/2023
/ Artificial Intelligence ,
Biotechnology ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Digital Health ,
Drug Distribution ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Investment ,
Machine Learning ,
Pharmaceutical Industry ,
Telemedicine
The expansion of over-the-counter (“OTC”) drug options has been a long time coming. Advocates in various fora, including within the U.S. Food and Drug Administration (“FDA” or the “Agency”), have focused on the potential for...more