Tag: IND

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

Posted on digi By digi

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…

Read More “Translational Packages: Nonclinical to First-in-Human—What FDA Expects” »

US Regulatory Submissions

Digital Health & SaMD in Trials: Do You Need an IDE or IND?

Posted on digi By digi

Digital Health & SaMD in Trials: Do You Need an IDE or IND? Digital Health & SaMD in Clinical Trials: A Practical Guide to Choosing IDE vs IND and Writing an Inspection-Ready Rationale Outcome-first thinking: when does a digital tool trigger IDE vs IND—and why it matters to speed and scrutiny Start with the primary…

Read More “Digital Health & SaMD in Trials: Do You Need an IDE or IND?” »

US Regulatory Submissions

US Oncology INDs: Safety Stopping Rules & DMC/DSMB Interfaces

Posted on digi By digi

US Oncology INDs: Safety Stopping Rules & DMC/DSMB Interfaces Designing Safety Stopping Rules and DMC/DSMB Interfaces for US Oncology INDs: A Practical, Inspection-Ready Playbook Why oncology trials live or die on their safety governance—and how to make it decisionable from Day 0 Begin with the decisions your trial must survive Oncology development stresses clinical safety…

Read More “US Oncology INDs: Safety Stopping Rules & DMC/DSMB Interfaces” »

US Regulatory Submissions

CMC Stability & Specifications for IND: Phase-Appropriate Justification

Posted on digi By digi

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…

Read More “CMC Stability & Specifications for IND: Phase-Appropriate Justification” »

US Regulatory Submissions

Drug-Device Combination INDs: US Submission Nuances & Traps

Posted on digi By digi

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…

Read More “Drug-Device Combination INDs: US Submission Nuances & Traps” »

US Regulatory Submissions

Bridging Foreign Data in US INDs: Acceptability & Evidence Strategy

Posted on digi By digi

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…

Read More “Bridging Foreign Data in US INDs: Acceptability & Evidence Strategy” »

US Regulatory Submissions

IND on a Budget—What Not to Cut (Small Sponsor Tactics)

Posted on digi By digi

IND on a Budget—What Not to Cut (Small Sponsor Tactics) IND on a Budget—Smart Cuts, Not Blind Cuts: Small-Sponsor Tactics that Preserve Speed and Reviewability Outcome-Oriented Budgeting: Buy Time, De-Risk Holds, and Keep Your First-Patient-In Date Define the decision gates before you cut a dollar Lean programs win by funding decisions, not documents. Before trimming,…

Read More “IND on a Budget—What Not to Cut (Small Sponsor Tactics)” »

US Regulatory Submissions

US vs EU Early Advice: FDA Meetings vs EMA Scientific Advice

Posted on digi By digi

US vs EU Early Advice: FDA Meetings vs EMA Scientific Advice Early Advice Pathways Compared: Getting Actionable FDA Meeting Outcomes vs EMA Scientific Advice (with UK/Global Notes) Why early advice determines your development velocity—and how to aim for decisionable outcomes Begin with a decision map, not a calendar Whether you pursue US or EU first,…

Read More “US vs EU Early Advice: FDA Meetings vs EMA Scientific Advice” »

US Regulatory Submissions

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

Posted on digi By digi

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…

Read More “Type A/B/C Meetings: Questions That Get Actionable FDA Feedback” »

US Regulatory Submissions

Pre-Submission Briefing Book: Structure, Evidence & Reviewer-Friendly Writing

Posted on digi By digi

Pre-Submission Briefing Book: Structure, Evidence & Reviewer-Friendly Writing How to Build the Pre-Submission Briefing Book: Structure, Evidence, and Writing that Makes Reviewers Say “Yes” Outcome-Oriented Briefing Books: Design for Decisions, Not Description Start with the decision, then backfill the evidence The most effective pre-submission briefing books begin with what you want the Agency to decide…

Read More “Pre-Submission Briefing Book: Structure, Evidence & Reviewer-Friendly Writing” »

US Regulatory Submissions