The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors interested in participating in the Advanced Manufacturing Technology (AMT) designation program. In response to ...
The U.S. Food and Drug Administration (FDA) recently launched two initiatives to help onshore U.S. pharmaceutical manufacturing: the FDA PreCheck Program to streamline review of pharmaceutical ...
Omnibus brings new advanced manufacturing programs to FDA The recently enacted ominous spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to ...
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 ...
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