UPDATE | June 27, 2026

PharmTech’s regulatory roundup for May 2026

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PharmTech's May 2026 Regulatory Roundup covers the FDA's launch of one-day inspections, Elsa 4.0 AI upgrade, and final CMC flexibility guidance for cell and gene therapies — which Samsung Biologics' Abigail De La Pena Garcia called "a significant step forward" formalizing a "more flexible and scientifically driven regulatory approach."


Read the full roundup for a complete breakdown of the month's regulatory developments.

PharmTech's May 2026 Regulatory Roundup covers the FDA's launch of one-day inspections, Elsa 4.0 AI upgrade, and final CMC flexibility guidance for cell and gene therapies — which Samsung Biologics' Abigail De La Pena Garcia called "a significant step forward" formalizing a "more flexible and scientifically driven regulatory approach."


Read the full roundup for a complete breakdown of the month's regulatory developments.

#Cell and Gene Therapies

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