• FDA Publishes Guidance For Biopharma Container & Carton Label Design

    The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA. It does not directly apply to OTC drug products, compounded products, or investigational products, but the principles may still be useful to prevent improper use of those products.

  • Assessing Extractables & Leachables In Parenteral Drug Products

    Therapeutic complexity increases the potential risks associated with chemical composition of materials used for drug packaging. Leachables in drug or biological products are chemical compounds that originate from components that are used to store and deliver medicines. Extractables should be considered as potential leachables.

  • FDA Finds Drug Shortages Are Mostly Caused By Quality Issues

    New FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages recommends an RMP for drugs that treat rare diseases and conditions, drugs with no alternatives, sole source products, products with only one API or manufacturing site available, and drugs made in facilities where an Official Action Indicated has been issued.

  • AstraZeneca Implements A "Technology Uplift" Of Its Microbiology Labs

    Modern microbiology labs are busy, with a wide range of activities taking place from final product testing to auxiliary support such as quality control release checks on nutrient media. While instruments and equipment available to technicians can vary, AstraZeneca wanted a networkwide approach to modernizing its labs.

  • Biopharma In China: The Emerging Global Force Of Domestic Suppliers

    Though multinational corporation vendors have seen double-digit pandemic-related sales increases for bioprocessing supplies in China, the top domestic vendors have posted even higher growth rates. With domestic supplier prices significantly cheaper, quite a few Chinese biopharma companies are shifting their purchase of supplies.

  • Biopharma Partnerships: Key To Filling The Life Sciences Innovation Gap

    The life sciences industry is facing a significant slowdown due to patent expirations. Many organizations have not established a robust enough pipeline to overcome the revenue to be lost. To bridge this innovation gap, pharma CEOs will need to expand their use of alliances, in tandem with bolt-on M&A, as a pipeline booster strategy.

  • New ICH Q14 Guidance Applies QbD To Analytical Procedures

    ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life cycle management employing elements of quality by design (QbD) and risk management tools. This article also explains the differences between this enhanced approach and the traditional approach.






The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.

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