Contributing Editors

  1. FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters 10/1/2026

    The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

  2. August 2026 — CDMO Opportunities And Threats Report 9/28/2026

    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. ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions 9/28/2026

    A former FDA assessor explains how recent changes to the common technical document bring long-overdue updates to the submission process, accounting for greater data demands.

  4. Engineering Better ADCs, Part 1: MoA, Conjugation Chemistry, And More 9/24/2026

    The field has evolved considerably in antibody–drug conjugate (ADC) science. In this first article of a two-part series, let's discuss how to engineer better ADCs, covering MoA, conjugation chemistry, and more.

  5. US Pharma Reshoring: The Full Policy Timeline 9/17/2026

    As policy shifts and manufacturing investments reshape pharma supply chains, capacity constraints and global dependencies persist. Explore the implications for long-term resilience.

  6. The Reliance Trap: When Regulatory Strategy Becomes A Clinical Supply Problem 9/17/2026

    The wrong regulatory filing sequence can close faster pathways, delay importation, and consume shelf life. Here’s how regulatory strategy can reshape clinical supply.

  7. What FDA Inspectors Want From Your OOS File 9/16/2026

    Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.

  8. You Can't CAPA What You Can't Classify 9/16/2026

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

  9. AI Fills The Decision-Making Gaps In Process Analytical Technology 9/16/2026

    When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.

  10. Why Supplier Diversification Doesn't Ensure Supply Safety 9/15/2026

    Recent events show supplier count to be an incomplete measure of resilience. The more useful question is whether separate supply arrangements remain independent when a critical material, capability, or route fails.