PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical ...

Understand why the FDA's shift toward single pivotal Phase III trials requires establishing a drug's mechanistic hypothesis ...

As part of PharmTech’s coverage of CPHI Milan, Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, ...

Effective regulatory responses are concise and evidence-based, explicitly connecting observations to root cause, corrective ...

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

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 ...

Global trial expansion demands front-loaded supply planning and robust infrastructure, rather than reactive logistics once enrollment begins, to protect timelines and investigational product ...

Christy Owings, vice president and general manager of the Americas business unit at Thermo Fisher Scientific, discusses with ...

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 ...

PharmTech AI Pulse Check debuts: pharma experts tackle GxP 'slop,' multi-agent validation risk, OCR document mining, personalized mRNA cancer therapy.

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.