PharmTech AI Pulse Check debuts: pharma experts tackle GxP 'slop,' multi-agent validation risk, OCR document mining, personalized mRNA cancer therapy.
Global trial expansion demands front-loaded supply planning and robust infrastructure, rather than reactive logistics once enrollment begins, to protect timelines and investigational product ...
CGMP, Kerrigan concluded, is not a checkbox exercise but a lifecycle commitment to quality assurance. 1 Facilities that are slow to correct excessive process variability will continue to draw ...
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity. This week on ...
Understand why the FDA's shift toward single pivotal Phase III trials requires establishing a drug's mechanistic hypothesis ...
PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical ...
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits ...
FDA will review discrete IND modules during pre-IND rather than waiting for a full submission, with the goal of de-risking ...
Effective regulatory responses are concise and evidence-based, explicitly connecting observations to root cause, corrective ...
As cell and gene therapies move from bespoke academic protocols into commercial-scale manufacturing, the raw materials underpinning them are emerging as one of the most consequent ...
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