Tag: CDISC SDTM

Translational Packages: Nonclinical to First-in-Human—What FDA Expects

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Translational Packages: Nonclinical to First-in-Human—What FDA Expects Translational Packages for First-in-Human: What FDA Expects from Nonclinical Through Dose Justification Outcome-first translational strategy: how to earn confidence for first-in-human Define the decision you want the reviewer to sign Your first regulatory milestone is simple to state and hard to win: agreement that the available nonclinical evidence…

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US Regulatory Submissions

CMC Stability & Specifications for IND: Phase-Appropriate Justification

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CMC Stability & Specifications for IND: Phase-Appropriate Justification Phase-Appropriate CMC Stability and Specifications for IND: How to Justify What’s “Enough” Without Overbuilding Why phase-appropriate stability and specifications decide IND speed—and how to justify them Start with the decision you need FDA to make The immediate outcome for a US-first early development program is straightforward: acceptance…

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Drug-Device Combination INDs: US Submission Nuances & Traps

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Drug-Device Combination INDs: US Submission Nuances & Traps Drug–Device Combination INDs in the US: Practical Nuances, Hidden Traps, and an Inspection-Ready Playbook Why combination INDs are different—and how to avoid the traps that stall review Begin with PMOA and jurisdiction: the decision that shapes everything else Combination development succeeds or slips based on a single…

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Bridging Foreign Data in US INDs: Acceptability & Evidence Strategy

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Bridging Foreign Data in US INDs: Acceptability & Evidence Strategy Bridging Foreign Data into a US IND: An Inspection-Ready Strategy for Acceptability, Traceability, and Real-World Timelines Why bridging foreign data is a speed lever—and how to make it acceptable the first time Start with the regulatory outcome, then design the bridge For many sponsors, the…

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US Regulatory Submissions

Type A/B/C Meetings: Questions That Get Actionable FDA Feedback

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Type A/B/C Meetings: Questions That Get Actionable FDA Feedback Type A/B/C Meetings: Crafting Questions That Get Actionable FDA Feedback the First Time Outcome-first framing: the fastest path to “clear, actionable” answers Start with the decision you want, then write backwards Every successful Agency interaction starts with a decision list: what you want the review team…

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US Regulatory Submissions

IDE vs IND: Device vs Drug Pathways—How US Sponsors Decide

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IDE vs IND: Device vs Drug Pathways—How US Sponsors Decide IDE vs IND in the US: A Practical, Inspection-Ready Playbook for Choosing Between Device and Drug Pathways Outcome-oriented framing: how to pick the right pathway without losing months Start with the clinical objective and primary mode of action (PMOA) The fastest route to first-patient-in is…

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US Regulatory Submissions

CMC for INDs: Quality Module Essentials for Early-Phase Programs

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CMC for INDs: Quality Module Essentials for Early-Phase Programs CMC for INDs: Building an Early-Phase Quality Module That FDA Accepts and Sites Can Execute Why CMC drives first-patient-in: the early-phase essentials and how to show them Outcome focus: fitness-for-purpose over perfection For an initial Investigational New Drug application, Chemistry, Manufacturing and Controls (CMC) is about…

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US Regulatory Submissions

IND Application Checklist: Modules, Forms, Timelines & Common Deficiencies

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IND Application Checklist: Modules, Forms, Timelines & Common Deficiencies IND Application Checklist: A US-First Guide to Modules, Forms, Timelines, and Fixing Common Pitfalls What an “inspection-ready” IND looks like—and why it matters for US/UK/EU sponsors Outcome definition: faster first-patient-in without regulatory rework An inspection-ready Investigational New Drug submission balances scientific credibility, procedural compliance, and operational…

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US Regulatory Submissions