PharmTech AI Pulse Check debuts: pharma experts tackle GxP 'slop,' multi-agent validation risk, OCR document mining, personalized mRNA cancer therapy.
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 ...
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory ...
Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains how AI is integrated into ...
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 ...
Effective regulatory responses are concise and evidence-based, explicitly connecting observations to root cause, corrective ...
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 ...
Since July 2026, the European Union (EU) has shifted its focus from legislative reforms to practical applications, prioritizing supply-chain resilience, preventing medicine shortages, streamlining ...
Christy Owings, vice president and general manager of the Americas business unit at Thermo Fisher Scientific, discusses with ...
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