On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.
News|Videos|August 31, 2026
Regulatory Roundup—August 2026
Author(s)Susan Haigney
In August 2026, Heidi Overton was nominated for FDA commission, and a wave of oncology and neuro drugs were approved.
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In August 2026, a new FDA commissioner was nominated by the White House; there was a variety of novel drug approvals spanning oncology to narcolepsy; and parallel moves from the United Kingdom's MHRA and Europe's EDQM were made to modernize standards—all set against tightened manufacturing scrutiny on both sides of the Atlantic.
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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.
Christy Owings, Thermo Fisher, on why early supply chain partnership and site visits prevent costly eCOA and clinical trial delays.
Christy Owings, Thermo Fisher, on how AI complements clinical supply chain expertise, streamlines site logistics, and tracks shifting biotech markets.
Christy Owings, Thermo Fisher, speaks on why importer of record strategy and vetted local partners are key to reliable clinical trial supply chains.
In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol Myers Squibb, discuss navigating CMC requirements for new modalities and AI’s involvement in CMC.
Christy Owings, Thermo Fisher, discusses how customs delays and import complexity risk clinical trial supply chains in Latin America.
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