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FDA introduces new pilot programme to accelerate early-stage clinical research
The US Food and Drug Administration (FDA) has outlined a series of actions to accelerate and modernise clinical research from the Investigational New Drug phase through to late-stage pivotal studies.
Industry news
EMA launches new pre-submission interactions model pilot
Beginning in September 2026, the European Medicines Agency (EMA) has invited marketing authorisation applicants to participate in an 18-month pre-submission interactions (PSI) model pilot.
FDA launches final guidance on therapeutic equivalence evaluations
The US Food and Drug Administration (FDA) has issued its final guidance on making therapeutic equivalence evaluations and assigning therapeutic equivalence (TE) codes.
FDA consults on the regulation of GenAI-enabled medical devices
The US Food and Drug Administration (FDA) has released a discussion paper to gather feedback on topics relevant to the regulation of generative artificial intelligence (GenAI)-enabled medical devices.
FDA finalises guidance aimed at widening access to cancer clinical trials
The US Food and Drug Administration (FDA) has finalised two guidance documents designed to help sponsors, Institutional Review Boards (IRBs) and investigators stop unnecessarily excluding cancer patients from clinical trials.
New diabetes treatment and a Vetmedin referral: Inside the CVMP July 2026 meeting
The July meeting of the Committee for Veterinary Medicinal Products (CVMP) covered product opinions, a Union referral, scientific advice outcomes, and several guideline updates spanning fixed combinations, novel RNA-based therapies and pharmacovigilance.
CHMP July meeting brings first-of-its-kind eye implant and oral psoriasis breakthrough
At its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 new medicines for marketing authorisation (three generics, one biosimilar, and eight extensions of indication), while issuing negative opinions on three applications.
More news
CVMP June 2026 meeting update: Vaccines, guideline reviews and an AMR strategy refresh
FDA launches new guidance on development of psychedelic drugs to treat medical conditions
USP 2025 Annual Drug Shortages Report: Shortages decline but duration increases
EU roadmap sets out 22 actions to phase out animal testing in chemical safety assessment
New MHRA framework sets out IMA pathway for rare disease therapies
FAST-EU pilot delivers first results: 70-Day approval timelines prove feasible ahead of Biotech Act
European Commission publishes first joint clinical assessment under EU HTA regulation
FDA launches Operation TrialBlazer to accelerate US clinical research
European Commission targets high-risk AI with new draft guidelines
The HMA-EMA NDSG publishes report on AI in medicines development
MHRA releases AI Airlock Phase 2 programme report
The National Commission into the Regulation of AI in Healthcare releases survey findings
