Regulatory Articles

  1. FDA Seeks Input On AI Adoption In Drug Development And Manufacture 6/13/2023

    The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.

  2. How Predictive Can Regulatory Drug Abuse Potential Investigations Be in Animals? 5/31/2023

    Is addiction attributed to “the animal or the human within us” or is substance abuse unique to humans? This question has intrigued me since the EMA guidance on Non-clinical Investigation of the Dependence Potential of Medicinal Products in 2006 and the FDA guidance on Assessment of Abuse Potential of Drugs in 2010 have requested the performance of dedicated studies in animals. Let's take a closer look at the matter.

  3. Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems 4/20/2023

    While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.

  4. Congressional Changes For Orphan Drug Approvals? 4/18/2023

    Lawmakers are stepping in to increase the number of rare disease and orphan drug experts who sit on advisory committees. As it stands now, advisory committees can include experts who simply have a broad understanding of the overall disease state.

  5. Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny 3/27/2023

    We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.

  6. Nanoparticle Engineering Addresses The Challenge Of Poor Aqueous Solubility 3/24/2023

    As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.

  7. Navigating Claim Scope For Functionally Claimed Biological Compounds After Amgen v. Sanofi 3/14/2023

    It can be difficult for broad biological compound claims to meet the two requirements in patent law that are used to “police” claim scope: the enablement requirement and the written description requirement. This article discusses the future of these types of patent claims after two Federal Circuit cases, Amgen v. Sanofi and Juno v. Kite.

  8. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

    Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

  9. ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity 3/7/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.

  10. ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-Based Decisions 2/28/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.