In-depth analysis and the VigiEye View on regulatory, pharmacovigilance, quality and market-access developments, built from the official records and linked to every source.
The EU's Article 31 review of injectable iron asks whether current risk-minimisation measures work. QPPVs should be able to answer that for their own products before a committee does.
FDA's NAION order covers every GLP-1 receptor agonist. QPPVs should stop treating class-wide safety as a competitor's problem and build standing class-level surveillance.
This week's records show regulators bridging gaps with imports, special programmes and allocation. Pricing and access teams that stop at the listing are measuring the wrong thing.
Accelerated approval bids on novel biomarkers and EMA's draft assay guideline point the same way: the measurement is now part of the regulatory claim, and teams should treat it like one.
FDA's Zolgensma probe cites confirmed vector insertional oncogenesis involving GLI1. Every AAV pharmacovigilance team should ask now whether its own malignancy surveillance could detect the same mechanism.
A pilot has become an established service, and the evidence questions in this week's records show why market access teams should treat joint regulator-HTA dialogue as part of planning, not a curiosity.
CMS has made Medicare price negotiation a lasting framework and MHRA-NICE has turned its RWE dialogue from pilot into service. Access teams should respond with standing functions, not one-off projects.
The camizestrant report shows the JCA is now producing output. Access teams that treat it as a shortcut will lose time to those who treat it as the first input into every national process.
MHRA's interim advice on givinostat, issued with no UK deaths reported, shows the signal can start elsewhere. QPPVs should decide in advance how their systems respond.
Italian registry forms, US payment codes and state Medicaid policies decide who gets a product, and they change on their own schedule. Market access teams should track them as access events.
A PRAC look at batch-linked allergic reactions to immunoglobulins, plus a week of lot-specific recalls, shows that the batch is often the unit of risk. Most PV systems still treat it as a free-text field.
AABB's first certification under its new quality-management programme assesses the system, not the cellular products. Compliance teams should treat that distinction as a rule, not a footnote.
This week's records show regulator notices that misdescribe, under-describe or are relayed second-hand. Teams that act on summaries are building compliance on sand.
Six PSUSA maintenance outcomes, a safety-label change list and a new QRD Appendix V landed in days. Treat them as one workflow, not as filing noise.
FDA's final potency assurance guidance spans development to post-market verification. With accelerated approvals in play, the strategy is part of the evidence package.
AIFA's latest notices show a retrospective bill arriving on a 30-day clock while two oncology products miss the innovation label. Italian price models should treat both as one decision.
When pipelines are assembled through acquisitions and options, the sponsor's operational readiness should be tested at the deal table, not discovered after the IND clears.
A mixed-strength carton, a syringe grip, a loose vial crimp and metal shavings in an antacid: this week's recalls argue for treating presentation as a critical quality attribute.
ACT EU's pre-submission advice pilot becomes permanent in January 2027. Sponsors should plan for it now, even though the evidence on what it delivers is not yet public.
A diagnostic recall with 58 complaints and zero adverse events shows why PV teams must stop treating an empty event field as evidence of safety.
EMA's new notice on computerised systems lands as sponsors run parallel programmes and readouts hinge on safety data. Validation belongs in trial design, not in the IT queue.
This week's field safety notices, recalls and reporting campaigns show patient risk arriving through hardware, software and preparation steps. PV teams need a view across all of them.
This week's launch updates show how far commercial availability sits from reimbursed, routine use. Market access teams should measure the gap and plan to close it.
This week's FDA drafts and an open BsUFA docket show regulators asking for input before the hard details are fixed. Teams that wait for final documents will inherit rules they could have shaped.
This week's recalls, a cyber-disrupted manufacturer and a new EMA notice on computerised systems point the same way: post-authorisation control matters as much as the dossier.