Analysis of regulatory developments across pharma and medtech, reviewed before publication.
10 public insights found.
FDA has issued May 2026 recommendations for food-effect studies in IND programs supporting NDAs and supplements, replacing part of its 2002 food-effect bioavailability and fed bioequivalence guidance.
The new M15 guidance signals that model-informed drug development evidence should be planned, evaluated, documented and submitted using a common ICH assessment vocabulary—part of a broader FDA pattern of making ICH outputs available for US regulatory use.
FDA’s latest device classification actions give medtech teams a practical reason to revisit pathway assumptions: newly codified Class II special controls may shape future 510(k) strategies, while separate exemption guidance could change submission expectations for some unclassified devices.
The final rule signals FDA’s preference for a controlled, device-specific pathway for certain anatomy-altering weight-loss technologies rather than treating them as either low-risk devices or automatically highest-risk products.
The extension gives sponsors and digital-health teams more time to shape FDA’s thinking on AI-enabled early-phase trial optimization, while a separate software recall signal underscores why validation and user-facing behavior remain central regulatory concerns.
EMA’s July R&D stakeholder platform gives generic and hybrid developers a near-term checkpoint: review 2026 product-specific BE guidance candidates and align protocols with the ICH M13A transition.
Final, nonbinding guidance gives sponsors a concrete reference point for IND-stage development, while a September public hearing opens a separate discussion about supervised use, provider readiness, access and post-approval data.
Regulatory-affairs teams should connect quality, risk, complaint, manufacturing and post-market processes now, while preserving market-specific procedures and evidence packages.
EU and UK initiatives now make early comparator selection, prespecification and bias control central to regulatory RWE planning, while stopping short of routine acceptance.
The class-wide procedure puts existing risk-minimisation measures under scrutiny and calls for coordinated safety-evidence and referral planning across affected portfolios.
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