Industry Insights

31. Leveraging AI To Assess Clinical Trial Technologies 6/13/2019

    As part of our ongoing series detailing an approach for the rapid assessment and prototyping of digital and other clinical trial technologies, we introduce here the use of artificial intelligence (AI) and machine learning (ML) to optimize clinical study design and execution. 

32. Which Testing Does An Effective Certificate Of Analysis Include? 2/16/2022

    Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

33. Fluid Management Equipment Market Poised For Growth In Europe 12/7/2020

    In the gynecology market, as the use of hysteroscopes and other less invasive methods increases, more procedures will require the use of fluid management equipment. Notably, there has been significant growth in the sales of both capital equipment and tubing for fluid management during hysteroscopic procedures. This article discusses the current and future fluid management market in Europe.

34. Improving Governance And Compliance With Knowledge Management 4/23/2024

    Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs.

35. Pre-IND Meetings: How To Achieve Success For 505(b)(2) 8/27/2021

    One of the greatest mistakes that the sponsor of a 505(b)(2) can make is to have an unsuccessful Pre-IND meeting. Read about the tools for making the Pre-IND meeting successful.

36. Expanding Clinical Trials Internationally In The ATMP Space 6/26/2025

    Discover how the global expansion of ATMP trials offers significant advantages but demands early, strategic planning to overcome complex international challenges.

37. Have You Selected The Right Stopper For Your Lyophilized Drug Product?

    Component selection is a complex process. Packaging considerations should occur concurrent with drug development to mitigate risk at every step of the drug development process.

38. Using The 505(b)(2) Pathway: Efficient Regulatory Approval For Combination Products 10/28/2021

    This blog post provides background on the regulatory submission and approval process for combination products and explores how developers may use a streamlined NDA process known as the 505(b)(2) pathway to reduce the size and/or scope of the nonclinical and/or clinical program for eligible combination products.

39. Development And Manufacturing: Success With HPAPI

    Dr. Michiya Hayakawa shares strategies for manufacturing HPAPI (highly potent active pharmaceutical ingredient) drugs and key points for promoting projects that utilize special formulation technologies.

40. 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.