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51. Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing? 5/21/2024

    Variability is inherent to biologics manufacturing. The trick is to catch it quickly and prevent product quality drift. That’s where the new ICH Q14 comes in.

52. New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies 5/16/2024

    The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.

53. What You Should Know About The FDA's New Final Rule On LDTs 5/14/2024

    The FDA made a small change with big consequences when it amended its definition of in vitro diagnostics. Here’s what it means for lab-developed tests.

54. Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations 5/6/2024

    Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.

55. Cell Counting Is Growing More Important Amid Advanced Therapy's Rise 4/12/2024

    You can't improve what you don't measure. This discussion explores advances in cell counting technology and the growing number of ways it aids the biotech industry and beyond.

56. FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions 4/11/2024

    The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.

57. AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance 4/8/2024

    The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.

58. When Does GMP Matter In Non-GMP Settings? 4/5/2024

    Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.

59. 2024 LIMS Trends 3/15/2024

    The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.

60. Notable Public Comments On The FDA's Proposed Regulation For Laboratory Developed Tests 3/12/2024

    The proposed FDA regulation for laboratory developed tests marks a significant step toward the FDA trying to standardize oversight for these diagnostic tools. As the FDA seeks public input, it is a hot topic as stakeholders grapple with the implications of increased regulatory scrutiny, debating its impact on patient access, innovation, and the overall landscape of diagnostic testing in the U.S.