However, as groundbreaking as these therapies are, they also pose unique challenges for the drug development process, particularly regarding quality assurance (QA). The role of QA is more critical ...
Integrating novel technologies in drug development and quality control ... Data integrity in pharmaceutical quality assurance ...
The FDA updated the outbreak advisory for E. coli O157:H7 infections linked to slivered onions served on McDonald’s Quarter ...
This registration marks the first approval of a treatment for use against foodborne pathogens, such as Salmonella and E. coli ...
Ensuring Quality and Compliance in Pharma: Insights from Outsourced Pharma’s CDMO Selection Webinar”
In the rapidly advancing field of novel therapies, especially in areas like cell and gene therapies, ensuring rigorous ...
The U.S. Food and Drug Administration has lifted a clinical hold on three cell therapies being developed by CARsgen ...
In particular, FDA observations highlighted issues around microbial quality assurance, with the agency reporting "insanitary conditions" at Humacyte's facility. News of this regulatory feedback ...
The resource most commonly reported by DICs as useful was Micromedex Healthcare Se ries, followed by MEDLINE and AHFS Drug Information. The percentage of DICs with formal quality assurance ...
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