Featured Outsourcing Editorial

  1. UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk 3/20/2026

    Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

  2. February 2026 — CDMO Opportunities And Threats Report 3/20/2026

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

  3. COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy 3/20/2026

    Problems emerge when development, manufacturing, and clinical priorities fail to converge in cell and gene therapy development.

  4. All The Ways Global Biopharma Still Grapples With Annex 1 3/19/2026

    Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.

  5. FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address 3/17/2026

    For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework. The public comment period ends May 8.

  6. Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables 3/17/2026

    A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

  7. Where Contamination Control Really Breaks Down In Practice 3/13/2026

    Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

  8. Trends In FDA FY 2025 Warning Letters 3/13/2026

    The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends.

  9. SUS Interchangeability Assessment And Qualification Best Practices 3/12/2026

    Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.

  10. Delivery Strategy For Next-Gen Cardiac Gene Therapies 3/12/2026

    As the field matures, the most transformative gene therapies in heart health are treating delivery not as an afterthought but as a fundamental principle.