With the FDA’s rule in place, sponsors now have clearer regulatory footing to submit nonclinical data generated through validated alternative methods as part of IND and marketing applications, though ...

Jaenisch, Muraru, and Pandey debate whether AI "slop" is infiltrating pharma SOPs and deviation reports and who should catch it first.

Patrik Florencio | Authors | Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and expert industry news.

Informa’s closed-door Leadership Summit convenes C-suite stakeholders to stress-test manufacturing and supply strategies under resource nationalism, export controls, and reshoring incentives reshaping ...

David S. Thompson, CSAP, is Chief Alliance Officer at Eli Lilly and Company.

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 ...

Jaenisch, Muraru, and Pandey debate whether AI "slop" is infiltrating pharma SOPs and deviation reports and who should catch ...

This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory ...

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 ...