A discussion paper released by the US Food and Drug Administration (FDA) on incorporating artificial intelligence (AI) and advanced manufacturing techniques into the pharmaceutical manufacturing ...
The FDA’s Center for Biologics Evaluation and Research (CBER) granted NanoMosaic’s request for an Advanced Manufacturing Technology (AMT) designation for its Nanoneedle technology for multiplex ...
(RTTNews) - Vericel Corporation (VCEL) announced that the U.S. FDA has approved commercial manufacturing of MACI at its new state-of-the-art cell therapy facility in Burlington, Massachusetts. The ...
Hovione, a global integrated specialist CDMO, and Industrial Design Consultancy Ltd (IDC), an international product ...
CHARLOTTESVILLE, Va.--(BUSINESS WIRE)--LumaCyte, a trailblazer in advanced label-free cellular bioanalytical technology and instrumentation, proudly announces the launch of the Laser Force Cytology™ ...
On September 12, the US Food and Drug Administration (FDA) released guidance detailing its approach to using alternative tools, such as remote regulatory assessments (RRAs), information sharing with ...
The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to ...
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