When the Scientist Is an Agent: Governing AI Before It Reaches the IND
Ono Pharmaceutical's rollout of agentic AI to every discovery scientist exposes a governance gap that sits upstream of any device or wearable regulation.
Find here all our blog posts tagged with: life sciences.
Agentic AI in Clinical Trials Isn't Exempt From High-Risk Classification
Agentic AI tools for trial design look administrative, but EU AI Act and MDR overlap rules can pull them into conformity assessment regardless of vendor intent.
AI Drug Discovery's Capital Boom Sits Outside the Regulatory Perimeter, Not Ahead of It
Discovery-stage AI funding is surging, but the mismatch compliance leaders should track is structural, not a simple case of regulation lagging money.
The Traceability Debt Building Inside AI-Native Drug Discovery
Closed-loop AI discovery platforms are compressing timelines faster than biopharma governance functions can build the audit trail regulators will eventually demand.
AI Discovers Drugs. It Doesn't Approve Them.
AI drug discovery has drawn billions in investment but zero FDA approvals, and the bottleneck sponsors need to plan for is evidence, not speed.
The AI Drug Discovery Boom Is Outrunning Trial Execution
Generative AI is accelerating molecule design, but no AI-discovered drug has cleared trials, and regulators have yet to define how AI governs the trials themselves.
The Trial Floor Is the Next Oversight Line, Not the Device Shelf
FDA's closed RFI on AI-enabled early-phase trials signals a second oversight track distinct from device review, and sponsors are moving faster than either.
The Convergence Gap in AI Life Sciences Regulation
Regulators describe AI, digital health, and clinical trial law as converging, but FDA, UK, and Chinese actions show the frameworks are still moving on separate, misaligned tracks.
When AI Guides the Hands, Not Just the Read
FDA's clearance of real-time ultrasound guidance AI creates a task-shifting risk category that standard imaging AI governance does not address.
The Next Regulatory Question Isn't the Model. It's the Data It Rescued.
AI-driven reanalysis of failed clinical trials is producing new evidence outside the systems built to validate it, and GxP quality frameworks have not caught up.
When AI Guides the Scan, Governance Must Follow the Hands
FDA's clearance of real-time AI ultrasound guidance software shifts imaging AI governance from diagnostic accuracy to human-AI interaction validation.
The Oversight Question Autonomous Diagnostic AI Hasn't Answered
FDA's latest device clearances shift AI from assistive to autonomous interpretation, and compliance teams still lack a shared standard for human oversight.
AI Governance's Real Fault Line Is Classification, Not Geography
Divergence in AI rules across the US, EU, and China is driven less by geography than by conflicting definitions of what counts as a regulated AI function.
Cleared, Qualified, Authorized: Three Different Promises
Regulated buyers are treating FDA clearance, institutional platform qualification, and De Novo authorization as interchangeable seals when they carry different evidentiary weight.
The Clinical Trial Has No AI Rulebook
Sponsors are deploying AI across trial execution with no dedicated regulatory framework, leaving GCP and data integrity obligations to fill the gap alone.
EMA Moved First on AI. FDA Is Still Deciding How.
EMA's lifecycle-wide AI reflection paper and FDA's still-open genAI device rulemaking are running on different clocks, and neither is finished business for regulated buyers.
The EU AI Act Extension Is a Delay, Not a Reprieve
The Digital Omnibus pushes the EU AI Act high-risk deadline for medical devices to August 2027, but MDR/IVDR and EMA already require the same work now.
Europe's AI Act and MDR Are Being Rewritten at the Same Time
European regulators are revising the AI Act and MDR simultaneously, leaving life sciences compliance teams no stable baseline to build against.
The EU AI Act Reprieve Is a Timing Bet, Not a Pause
Digital Omnibus alignment gives AI-enabled medical devices breathing room on paper, but MDR/IVDR certification obligations have not moved and neither has the underlying risk.
Life Sciences Is Merging Two EU AI Act Obligations Into One
EU AI Act transparency rules for content marking and interaction disclosure are distinct obligations, and life sciences compliance teams keep treating them as one.
Europe's New Fast Lane for Breakthrough AI Devices Comes With No Governance Shortcut
The EU's new Breakthrough Devices framework under MDR/IVDR speeds review timelines but leaves AI governance obligations fully intact.
Europe's Dual Certification Trap for Clinical AI
AI systems that influence clinical decisions can trigger MDR and EU AI Act obligations at once, and the Digital Omnibus timeline does not change that exposure.
The Evidence Gap Behind AI Clinical Decision Support
AI decision support tools are scaling into hospitals faster than the evidence and oversight infrastructure needed to trust them.
FDA's AI Perimeter Is Widening and Narrowing at the Same Time
FDA is loosening wellness device classification while tightening AI change control mechanics, and the gap between the two is where compliance risk now sits.
FDA Clearance Is Not the Evidence Trail
FDA-authorized AI devices are outpacing the evidence behind their safety and equity claims, leaving health systems to build the diligence layer themselves.
FDA's Other AI Track: Drug Development Gets Its Own Playbook
While FDA's device guidance draws attention, a parallel track for AI in early-phase clinical trials and drug development is quietly taking shape.
The FDA-EU Fork in AI-Enabled Medical Devices
FDA is building adaptive, lifecycle-based pathways for AI-enabled devices while the EU stacks AI Act obligations atop MDR and IVDR, forcing a sequencing decision now.
The Benchmark Gap Inside FDA's AI Change Control Plans
FDA's Predetermined Change Control Plan guidance lets AI devices update without new submissions, but no validated benchmarking standard tells manufacturers where drift becomes risk.
FDA's New Deputy Commissioner Post Is the Real AI Signal
HHS is creating a dedicated technology leadership role at FDA, and that appointment will shape AI device oversight more than any single guidance document.
FDA's Three-Part Test for Agentic Devices
FDA's generative AI discussion paper outlines a safety, proficiency, and generalizability framework that will shape validation evidence long before formal guidance arrives.
The Generative AI Gap in FDA's Device Playbook
FDA has cleared over 1,000 AI-enabled devices, but generative AI features still lack a defined regulatory pathway, forcing sponsors to choose their architecture carefully.
In HealthTech M&A, AI Governance Is Now a Line Item on the Term Sheet
Buyers in HealthTech and MedTech deals are pricing AI governance maturity directly into valuation, not treating it as a closing condition.
The Governance Debt Building in Drug Discovery AI
Regulatory frameworks are expanding toward AI in drug development, but the real exposure is a silent-failure risk that neither hype skeptics nor regulators are pricing in yet.
The Governance Gap Belongs to the Deployer, Not the Regulator
Hospitals and pharma functions adopting generative AI now carry governance obligations that device and drug frameworks were never built to cover.
Your Patients Are Uploading Health Data Into a Regulatory Gap
Life sciences firms building patient-facing AI tools are relying on a HIPAA and FDA perimeter that consumer health AI routinely sits outside.
The PCCP Gap: FDA Lets AI Models Change, Europe Asks Which Model You Meant
FDA's finalized change control plans let AI-enabled devices update without new submissions, but EU classification law may treat the same update as a new device.
The PCCP Is the Real Clearance
FDA's predetermined change control plans, not the original device clearance, now define how far an AI-enabled medical device can drift without new review.
The PCCP Is the Real Decision, Not the Generative AI Docket
FDA's Predetermined Change Control Plan guidance, not the open generative AI docket, is the mechanism sponsors must decide on now for AI-enabled devices.
The Architecture Decision Pharmacovigilance AI Cannot Defer
Cross-jurisdictional data rules are forcing pharma safety teams to choose between centralized and localized AI architectures before regulators force the choice for them.
Quantum-Classical AI Enters Drug Discovery, Validation Frameworks Don't
Quantum-enhanced generative AI is moving into drug discovery pipelines faster than GxP validation and data integrity practices can absorb it.
The Guidance Cannot Outrun the Model
FDA and EU regulators are structurally too slow to govern AI at the pace it changes, so life sciences compliance leaders must build internal governance now.
The Platform Risk Hiding in Serial Clearances
Tempus AI's third ECG-based FDA clearance shows how one platform can accrete indications faster than buyers can verify its cumulative risk profile.
The New Fault Line: When Identical Hardware Faces Opposite FDA Rules
FDA's finalized wearable guidance means device classification now hinges on claims and labeling, turning product marketing into a regulatory control point.
