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FDA Draft Guidance on Gene Editing Safety (2026)
The FDA’s 2026 gene editing draft guidance could change your regulatory strategy. Explore the new NGS requirements for cell and gene editing therapies.
CRO and Vendor Oversight in Clinical Trials
ICH E6(R3) raises the governance bar for CRO and vendor oversight in clinical trials. Here's what sponsors must build into outsourcing relationships to protect trial quality and timelines.
Ready to Deliver With Continuous Pharmaceutical Manufacturing
Continuous pharmaceutical manufacturing cuts production time by up to 90% and is now backed by ICH Q13. Here’s what manufacturing leaders need to know about the shift to CM.
FDA PreCheck Pilot Program to Build Manufacturing Readiness
The FDA PreCheck Pilot Program aims to strengthen U.S. domestic drug manufacturing through regulatory engagement, manufacturing readiness, and advanced production.
Modular Pharma Factories: The Next Step for Continuous Manufacturing?
Discover how modular pharmaceutical manufacturing and continuous production could improve flexibility, resilience, and efficiency across modern pharmaceutical operations.
Blockchain Adds a Trusted Data Layer in Pharma Manufacturing
Blockchain in pharma manufacturing could strengthen traceability, data integrity, and supply-chain visibility. Pharmatica examines the evidence and barriers.
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