Featured Outsourcing Editorial

  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. CDMO Selection Beyond Capabilities And Price 9/30/2026

    Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.

  3. 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.

  4. Building Sustainable Biopharma Supply Chains Starts With Procurement 9/24/2026

    Nearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.

  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. Why You Should Measure Comparability Debt Before Ever Starting A Study 9/17/2026

    When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.

  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. 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.

  9. 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.

  10. Is mRNA Manufacturing Overbuilt? 9/15/2026

    mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.