New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, ...
A proof-of-concept study has created a blueprint for producing prostate cancer treatment more efficiently. Researchers at the University of Missouri, Cancer Targeted Technology (CTT) and ...
Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...
Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...
Adam Kovalčík, age 19, innovated a cheaper, faster way to produce an antiviral drug. Galidesivir targets RNA viruses like COVID-19, Ebola, and Zika but hasn't completed clinical trials. Kovalčík won a ...
FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...
An international team of researchers led by the University of California San Diego has developed a new strategy to enhance pharmaceutical production in Chinese hamster ovary (CHO) cells, which are ...
The Food and Drug Administration (FDA) is launching a new program to ramp up the United States’s domestic pharmaceutical supply chain, the agency announced Thursday. The program, called FDA PreCheck, ...
Scientists have developed a new strategy to enhance pharmaceutical production in Chinese hamster ovary (CHO) cells, which are commonly used to manufacture protein-based drugs for treating cancer, ...
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