The Regulatory Leadership Briefing
Insight & News
Field notes on the rules that move markets — written by the people who do the work.
Connor Griggs · 9 min read
The Regulatory Leadership Briefing
Field notes on the rules that move markets — written by the people who do the work.
Connor Griggs · 9 min read
The Ledger
Practical guidance on the regulations reshaping your work — written to be applied, not just read.
58 articles
Whether a product is an MDR device or a medicinal product comes down to one legal test — principal mode of action — and MDCG 2022-5 is the guidance manufacturers keep misapplying.
Connor Griggs · 9 min read
A specification that just cites the compendial monograph looks complete and isn’t. Q6A and Q6B build in decision trees for exactly this reason — and most CMC teams never walk through them.
Connor Griggs · 8 min read
The pathway promises a 30-day FDA review instead of 90 — but FDA converts a submission to Traditional mid-review the moment it fails one of three eligibility conditions.
Connor Griggs · 7 min read
A BCS Class I result is not itself a biowaiver. ICH M9 gates it separately on rapid dissolution and excipient risk — either can sink an otherwise clean classification.
Connor Griggs · 7 min read
An executed SPA agreement is written and binding — but FDA's own guidance names three conditions under which it can still revisit it.
Connor Griggs · 8 min read
A multi-regional trial isn't one protocol run in several places. ICH E17 expects the regional-consistency question planned before the trial starts.
Connor Griggs · 8 min read
A refuse-to-file letter is not a scientific verdict. It's FDA saying your NDA or BLA never cleared the completeness threshold that lets substantive review start.
Connor Griggs · 8 min read
Six product groups without a medical purpose — dermal fillers and colored contact lenses among them — now clear the same clinical and post-market bar as a Class III implant.
Connor Griggs · 8 min read
Regulation 2023/607 moved the legacy-device deadline to 2027 or 2028. The extension is conditional, and it can lapse quietly, long before the date arrives.
Connor Griggs · 8 min read
An estimand needs five attributes and a deliberate strategy for every intercurrent event. "Intent-to-treat" names neither — it is a default, not a specification.
Connor Griggs · 8 min read
Notifying a substantial modification takes a sponsor one week. Implementing it takes at least 38 days — and the two clocks get confused more often than the rule does.
Connor Griggs · 7 min read
A REMS can change outside the 18-month, 3-year, and 7-year assessment schedule. Treating it as static between checkpoints leaves sponsors exposed.
Connor Griggs · 7 min read
Under Annex VIII, Class I is a narrow leftover category. Most clinical software lands in IIa or higher the moment it informs a decision.
Connor Griggs · 7 min read
ICH Q5A(R2) governs viral safety. ICH Q5D governs the cell substrate underneath it — derivation, banking, and the tumorigenicity call teams skip.
Connor Griggs · 7 min read
ICH Q7 defines an API starting material as a significant structural fragment. ICH Q11's Q&A makes clear that test alone won't justify it to a reviewer.
Connor Griggs · 7 min read
FDA's March 2026 draft guidance defines what a Form 483 response must contain: one 15-business-day submission with risk assessment, root cause, and CAPA.
Connor Griggs · 7 min read
A design space under ICH Q8(R2) is a multidimensional, interaction-tested region — not a set of proven acceptable ranges filed one variable at a time.
Connor Griggs · 7 min read
Scientific validity is a distinct, evidenced pillar of IVDR performance evaluation — not a literature summary borrowed from MDR clinical evaluation habits.
Connor Griggs · 8 min read
A comparability protocol lets you write the CMC change plan before you need it, then execute the change at a lower reporting tier. The catch: the tier structure isn't the same for a BLA as it is for an NDA.
Connor Griggs · 7 min read
Option 1's residual-solvent table assumes every product is dosed at 10 grams a day. Off that assumption, the table under- or over-restricts the limit, and Option 2's dose-based calculation is the one the guideline actually expects.
Connor Griggs · 7 min read
FDA's May 2026 final guidance sorts every marketing submission into one of three Human Factors Submission Categories, and eSTAR has required the call since August 1. Category 2's rationale is where most teams fall short.
Connor Griggs · 8 min read
Article 86 gets described as an annual PSUR requirement. Class IIb and III update annually — Class IIa only when necessary, at least every two years — and the notified body review path splits the same way.
Connor Griggs · 8 min read
The sponsor makes the first significant-risk call under 21 CFR 812.3(m), but the IRB can overturn it under 812.66 — and FDA's own determination, wherever it comes from, is final and controls over both.
Connor Griggs · 7 min read
Articles 13 and 14 give importers and distributors their own verification and complaint duties. A manufacturer's CE mark doesn't discharge them, and a supply contract can't sign them away.
Connor Griggs · 8 min read
ICH Q5A(R2), finalized November 2023 and adopted by FDA in January 2024, extends viral safety evaluation to viral-vector gene therapy products and accepts next-generation sequencing for virus detection. The scope boundary that matters for CGT sponsors is narrower than the headline: replication-competent, self-replicating products stay out.
Connor Griggs · 7 min read
Finalized alongside ICH Q14, Q2(R2) revised the validation-characteristics framework analytical teams have run for decades. The acceptance criteria a protocol needs now trace to the procedure's stated purpose, not a fixed category checklist.
Connor Griggs · 7 min read
Most sponsors read a Complete Response Letter for the deficiencies. FDA reads the resubmission for scope — and reclassifying it from Class 1 to Class 2 doesn't shorten the clock, it resets it.
Connor Griggs · 7 min read
A folder of risk assessments filed under the name “CCS” looks compliant until an inspector asks who owns it. Annex 1 expects one governed strategy, not a compliance artifact assembled after the fact.
Connor Griggs · 7 min read
Most vigilance procedures default to a single 15-day timer. Article 87 actually sets three — and the fastest one starts on suspicion, not confirmation.
Connor Griggs · 7 min read
Most CMC teams can recite “0.1%” from memory. It isn't in the guideline's default table — the real thresholds are three tiers that move with the dose.
Connor Griggs · 7 min read
Most complaint-handling teams know the 30-day clock under 21 CFR 803.50. Fewer can name the two specific conditions in §803.53 that shorten it to 5 work days — and getting that call wrong runs in both directions.
Connor Griggs · 7 min read
ICH M7's TTC gets quoted like a universal ceiling. It's a starting point for one exposure duration — and the classification workflow that precedes it decides whether it even applies.
Connor Griggs · 7 min read
Designation buys faster FDA access, not a lower bar. Why Sprint discussions and a negotiated Data Development Plan decide what happens at pivotal review — and why waiting until the deficiency letter is using the program backwards.
Connor Griggs · 6 min read
Annex XIV, Part B has governed PMCF since MDR applied. What separates an objective a Notified Body accepts from one that just restates the regulation — and when “not applicable” actually holds up.
Connor Griggs · 7 min read
Full and partial validation carry fixed numeric acceptance criteria. Cross-validation deliberately doesn't — and importing one from elsewhere in the guideline is the mistake reviewers catch.
Connor Griggs · 7 min read
Annex 1 makes pre-use integrity testing the default on every sterilizing filter. What a compliant risk assessment must document to justify skipping it — and why it has to live inside the Contamination Control Strategy.
Connor Griggs · 7 min read
FDA's Dec 2024 final guidance sets three required PCCP elements for AI-enabled devices. What each has to document, and what changed from the 2023 draft.
Connor Griggs · 7 min read
A finished-product test against default limits is not a Q3D risk assessment. The source-by-source work the guideline actually requires, and what the 2022 revision changed in the PDE table.
Connor Griggs · 7 min read
FDA judges substantial equivalence on a two-prong legal test, not resemblance. Split predicates have been off-limits since 2014, and a 2023 draft guidance adds a documentation burden most 510(k) Summaries still skip.
Connor Griggs · 6 min read
The qualification pathways are the easy part to satisfy. The compliance exposure that survives an audit is a PRRC who holds the title without the organizational authority Article 15's duties actually require.
Connor Griggs · 6 min read
FDA has treated Q14 as guidance since March 2024. Filed under the minimal approach by default, an analytical procedure locks down every parameter as an established condition — and every future method tweak becomes a prior-approval change.
Connor Griggs · 7 min read
All six Class D EURL categories are now operational — four since October 2024, two more since May 2026. The distinction that trips manufacturers up: initial conformity verification versus the ongoing batch-testing obligation.
Connor Griggs · 8 min read
FDA's Q-Submission Program covers more than the Pre-Sub. File a Submission Issue Request within 60 days of a hold letter and FDA's stated aim is 21 days — a third of the clock teams get once that window closes.
Connor Griggs · 7 min read
Q13 has been FDA guidance since March 2023. Most control-strategy sections still read like an equipment description — not the traceability and diversion argument reviewers are actually looking for.
Connor Griggs · 8 min read
Basic UDI-DI and UDI-DI are not interchangeable. Here is which device changes force a new UDI-DI — and where the reconciliation across labeling, technical file, and EUDAMED actually breaks.
Connor Griggs · 7 min read
FDA finalized ICH E6(R3) in September 2025. The guideline replaces uniform, procedure-heavy monitoring with critical-to-quality factors identified during protocol design — not retrofitted onto a plan already written.
Connor Griggs · 7 min read
An FMEA ranks failure modes by severity and occurrence. ISO 14971:2019 asks for a full risk management system — a plan, acceptability criteria, and an evaluation of overall residual risk — and reviewers notice exactly which piece is missing.
Connor Griggs · 7 min read
Article 61 still lets a manufacturer rely on another device's clinical data instead of running its own investigation — but only where it can show a genuine, ongoing right to that device's technical documentation.
Connor Griggs · 6 min read
Section 524B requires a vulnerability-management plan and a secure-update process alongside the software bill of materials — and FDA's refuse-to-accept screen is catching submissions that skip them.
Connor Griggs · 6 min read
Regulation (EU) 2024/1860 gave legacy Class C diagnostics a path to 2028 — but only for manufacturers who convert a filed application into a signed Notified Body agreement by 26 September 2026.
Connor Griggs · 7 min read
The primary mode of action determination happens early, in a filing most sponsors treat as paperwork. It quietly sets your review pathway, your user fees, and which quality system you will run for the life of the product.
Connor Griggs · 7 min read
Three of ICH Q10's four pharmaceutical quality system elements produce data. The fourth is supposed to act on it. Most companies run a meeting that reports the data and calls that management review.
Connor Griggs · 7 min read
Two years of transition ended on February 2, 2026. The manufacturers still exposed are not the ones without a certificate — they are the ones who mistook the certificate for the regulation.
Connor Griggs · 8 min read
The 2023 revision named the quiet failure modes of pharmaceutical risk management — subjectivity, ritual formality, decisions made before the assessment starts — and told industry to fix them. Most programs haven't.
Connor Griggs · 8 min read
The European database has been voluntary for years. A 2025 Commission decision set the clock for mandatory use — and the work that decides whether you make it is the data you don't have yet.
Connor Griggs · 8 min read
Established conditions, PACMPs, and the PLCM document are levers, not paperwork. Why most manufacturers capture none of the benefit — and how to change that before your next submission.
Connor Griggs · 7 min read
PMS remains the most common source of notified body findings, and the pattern is consistent: paperwork where a system should be. The recurring gaps, the EUDAMED clock, and how to build PMS that survives audit.
Connor Griggs · 9 min read
The statutory 30-day clock hasn't moved — almost everything around it has. Where a leaner, reorganized FDA actually changes your IND risk profile, and how to plan the interactions that remain.
Connor Griggs · 8 min read
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