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The US Food and Drug Administration (FDA) this week issued draft guidance detailing its new advanced manufacturing technologies (AMT) designation program, offering insights on submitting designation ...
NanoMosaic, Inc., a leader in advanced analytical technologies for cell and gene therapy development and manufacturing, today announced its strong scientific and commercial presence at the American ...
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 ...
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 ...
The US Food and Drug Administration (FDA) has announced increased flexibility for cell and gene therapy (CGT) manufacturers, loosening quality requirements in an effort to expedite patient access. The ...
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