Industry Insights

51. Certifying Exports: A Roadmap To EMA's Certificate Of Medicinal Product 2/8/2021

    In Part 1 of this series, we discussed requirements for exporting U.S.-manufactured material to foreign markets supported by an FDA-issued certificate of pharmaceutical product. Here in Part 2, we will explain how to export EU-manufactured product to foreign markets leveraging a certificate of medicinal product issued by the European Medicines Agency.

52. Draft Q&A Guidance Offers Roadmap For Biosimilar Post-approval Changes 7/31/2024

    FDA explains how it's looking to evaluate the effects changes might have on biosimilar products' identity, strength, quality, purity, and potency.

53. Quality Management Review For Compliance And Improvement 4/6/2022

    Read more about quality management review regulations, a typical quality management review and how to ensure the reviews happen on schedule and per procedures.

54. FDA Adopts ICH Guidance On Assessing Nonclinical Biodistribution Of Gene Therapy Viral Vectors 5/23/2023

    An important step in the gene therapy development process is assembling biodistribution data in suitable animals in relation to the intended clinical population. Developing an accurate biodistribution profile is influenced by factors such as the route of administration, dose level(s), dosing regimen, and the animal immune response to the gene therapy product. The FDA adopted this ICH guidance in May 2023, and the EMA plans to adopt it in September 2023.

55. Have We Got Novel Drug Production And Compliance Timelines All Wrong? 6/13/2024

    Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.

56. What Is A Viral Vector? 4/16/2024

    Review a novel adenovirus production process that offers scalable, single-use equipment-compatible solutions, reducing production time and cross-contamination risks.

57. FDA Recall Prevention: Save Time, Money, And Reputation 10/8/2024

    FDA product recalls pose significant challenges for life sciences companies. Avoid recalls with these actionable steps to mitigate risk, ensure compliance, and safeguard your organization's reputation.

58. Referencing A Listed Drug For The 505(b)(2) Pathway 8/27/2021

    Section 505(b)(2) of the Food, Drug, and Cosmetic Act describes a 505(b)(2) new drug application (NDA) as an application where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.

59. Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower Risk 1/18/2022

    Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

60. How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield 8/27/2024

    This article outlines strategies for reducing the volumes required for gene therapy stability studies, with the goal of conserving product for patients, while remaining compliant and delivering data on CQAs.