Regulatory Affairs Editorial

  1. Brazil's Regulatory Transformation: Building And Supporting Sites Beyond The AMCs 11/4/2026

    Our expert chat about Brazil’s clinical research transformation concludes with SBOC President-elect Fabio Franke, who explores building sustainable trial capacity beyond the country’s major AMCs.

  2. Brazil's Regulatory Transformation: Expanding Clinical Trial Participation 11/3/2026

    A discussion of Brazil’s clinical research transformation continues as this Q&A series turns to Maiko L. Tonini, Ph.D., of Brazil’s Ministry of Health, to explore expanding clinical trial participation.

  3. Washington's Clinical Trial Alphabet Soup 11/3/2026

    From FDA pilots to congressional proposals, Washington is taking aim at clinical trial delays, patient access barriers, and fragmented data. Dan Schell sorts through the initiatives and the practical questions that will determine whether they make a difference for sponsors, sites, and patients.

  4. Brazil's Regulatory Transformation: A New Era For Clinical Development 11/2/2026

    Brazil’s clinical research transformation takes center stage as this new Q&A series opens with Interfarma CEO and former ANVISA director Renato Porto.

  5. An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs? 10/28/2026

    FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

  6. What The New PDUFA Guidance Means For Drug Development 10/21/2026

    Learn how the FDA’s updated PDUFA meeting guidance affects sponsor engagement, preparation, and the way feedback shapes drug development.

  7. The New Clinical Trial Regulatory Landscape Balances Speed, Quality, and Compliance — Are You Ready? 10/19/2026

    Part one of this two-part series explores how clinical trial regulation aims to balance speed, quality, compliance, and digital innovation.

  8. Get Ready For Regulators With This Speed-Quality-Compliance Framework 10/19/2026

    Part two of a two-part series, experts Sapna Rani and Shaun Hastings offer a five-part framework to balance speed, quality, and compliance amid evolving clinical trial regulations.

  9. Your Company Needs Compliance Expertise — But When And From Whom? 10/8/2026

    When should a biotech formalize compliance? Learn how risk, funding, clinical activity, and commercialization shape the right expertise and structure.

  10. Calidi's Study Aims To Have An Oncolytic Virus Outsmart The Immune System 10/2/2026

    Calidi’s Eric Poma, Ph.D., explains how CLD-401 could evade immune clearance — and how the biotech is designing Phase 1 to prove safety and efficacy fast.