Industry Insights

11. Growing Complex Generic Application Load May Force US FDA Staffing Changes

    Staffing plans for complex generics and other FDA priorities may be complicated by the continual burden of the coronavirus pandemic. Learn what forced the agency to lower hiring and retention expectations earlier this year.

12. Optimizing FDA Submissions For Companion Diagnostics: Alternative Evaluation Pathways To Streamline Approval 6/17/2016

    In part one of this series, we examined the history of companion diagnostic approvals by FDA and identified trends to suggest better approaches to optimize the review process. Here, we will analyze new avenues sponsors may consider to further streamline the review of these important products through the assessment of various regulatory submission types and FDA guidance.

13. SARS-CoV-2: Massey Univ. Profs Develop Method To Quickly Sequence Genome 8/13/2021

    It was a matter of time before the world saw variants emerge that increased the transmission rate of COVID-19. A research team led by two of these authors at Massey University have developed a new next-generation sequencing method for the ultrafast sequencing of the SARS-CoV-2 genome, which cuts the sequencing time by more than half.

14. Analytical Considerations For Biopharmas During Commercialization

    As a project approaches its process performance qualification phase, it is crucial to understand the expectations of regulatory agencies and identify the most efficient ways to validate the analytical methods.

15. A Better Path For CMO Relationships As The Pandemic Continues 4/6/2022

    In this article, we discuss how drug sponsors and service providers can better work together to continue down the path of outsourcing success that has been highlighted during the pandemic.

16. CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance 12/21/2022

    While the concept of contamination control is not new, the EU's revised GMP Annex 1 requires a formally documented strategy specific to a facility. Under the new set of requirements, the “span of oversight” has shifted, and CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency with sponsors.

17. Optimize Scale-Up And Increase Capacity For Vaccine And Therapeutic Manufacturing 11/18/2020

    In order to accelerate development and manufacturing in the era of SARS-CoV-2, companies are designing scale-up processes in parallel with Phase III clinical trials, redefining the risk tolerance for everyone involved. Read this article to consider a new way of doing business by reviewing existing capabilities, assessing risk tolerance, and identifying key resources to accomplish your goals.

18. Getting The CAPA Framework Right The First Time 5/8/2024

    CAPA processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement.

19. Questions All Auditors Should Ask: The Use And Misuse Of Audit Checklists 4/7/2014

    There’s nothing wrong with using a good checklist, as long as you remember that there will always be something wrong with your checklist. It is simply not possible to develop a checklist that will get to the core of every problem, that will cover every scenario, or that will ever be any reasonable substitute for that all important question: "Why?"  How can you develop the best checklists possible and avoid relying on them too heavily? By Laurie Meehan, Polaris Compliance Consultants, Inc

20. Mobile Continuous Process Technology: A Collaborative Innovation Case Study 5/24/2017

    In Part 1 of this two-part article, we explored the role of open collaboration in the future pharmaceutical manufacturing innovation. This article provides a specific example of how such collaboration is already taking place, through a unique industry-academic partnership.