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FDA Finalizes Digital Health Technology Guidance Reshaping Remote Data Acquisition in Clinical Trials
FDA's final DHT guidance sets binding expectations for remote data acquisition in clinical trials, affecting protocol design and submission strategy.
Simantini Singh Deo
FDA Refreshes IND Safety Reporting Guidance Under 21 CFR 312.32 for IND Sponsors
FDA updates its IND safety reporting resource, clarifying 21 CFR 312.32 thresholds, timelines, and submission requirements for active IND sponsors.
Simantini Singh Deo
FDA Launches Guidance Snapshot Pilot Covering Master Protocols and Bayesian Methodology Drafts
FDA's Guidance Snapshot Pilot debuts with Master Protocols and Bayesian Methodology drafts, offering regulatory teams structured access to cross-cutting clinical trial guidance.
Simantini Singh Deo
Roche Gains FDA Priority Review for Colon Cancer Drug with October 2026 Decision Date
FDA grants Roche Priority Review for a colon cancer drug, setting a 9 October 2026 decision date after trial data showed 50% recurrence reduction.
Vaibhavi M.
