Featured Pharma Online Editorial

  1. Generative AI Can Write The Code, But Who Builds In The Quality? 3/23/2026

    Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.

  2. FDA's Final NDC Rule Provides A 900-Year Supply Of Label Codes 3/19/2026

    FDA won't offer a waiver process or phased implementation. Instead, the agency is providing a seven-year runway to transition to a new labeling format.

  3. Clearing The Fog On New First Air Visualization Expectations 3/18/2026

    Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.

  4. 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    For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework.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.

  5. From Pandemic Collaboration To Patent Litigation: BioNTech's Case Against Moderna 3/17/2026

    BioNTech’s new lawsuit against Moderna highlights the intensifying post-COVID mRNA patent wars, as companies clash over vaccine design, delivery technologies, and the future of RNA therapeutics.

  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    A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk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. Raising The Bar In Radiopharmaceutical Manufacturing 3/12/2026

    Ratio Therapeutics chief commercial and manufacturing officer, Scott Holbrook, joined me to discuss how his team at Ratio Therapeutics is tackling the challenges of radiopharmaceutical manufacturing.

  10. What To Know About — And How To Apply For — FDA's PreCheck Pilot 2/23/2026

    FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.