New FDA communication introduces a more flexible, risk‑based chemistry, manufacturing, and controls (CMC) framework for cell and gene therapies, including phased data submission to support earlier ...
Students from Yale Public Schools may now be inspired to enter the manufacturing industry after taking a field trip to Blue Water Controls. Blue Water Controls hosted sophomores from Yale High School ...
After the FDA issued a global recall last year of "sartan"-based drugs contaminated with a possible carcinogen, there's been plenty of blame to pass around. The most recent recipient of regulators' ...
Citius Pharmaceuticals Inc. appointed drug industry veteran Kelly Creighton as executive vice president of chemistry, manufacturing and controls, the company announced Nov. 5. Creighton will be ...
Aim: To demonstrate the potential of in-line nanoparticle size measurements using the NanoFlowSizer (NFS) as a PAT method. To achieve real-time process control by establishing automated regulation of ...
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