Premier Consulting Blogs

  1. New FDA Draft Guidance Provides Insights On Use Of Pros In Oncology Trials 7/26/2021

    Incorporating patient-reported outcomes (PROs) into clinical trials can help sponsors better understand patients’ symptoms and how a therapy will affect their quality of life. Read how that’s changed with the recent publication of a new draft guidance from the U.S Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), Core Patient-Reported Outcomes in Cancer Clinical Trials.

  2. Beware of Underestimating The Value Of A Pre-NDA Meeting 11/19/2020

    This blog covers the benefits and how to prepare for a pre-FDA meeting, what should be in your pre-NDA briefing package, potential topics for discussion as well as who should attend the pre-NDA meeting.

  3. 5 Tips To Avoid An IND Clinical Hold: Regulatory Guidance And Insights 10/19/2020

    A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging biopharma companies.

  4. Creating A Compliant eCTD: Avoiding Common Regulatory And Technical Pitfalls On The Path To Submission 7/27/2020

    Failure to comply with the regulatory and technical requirements when creating your eCTD could jeopardize the success of your submission and your product development plan as a whole, especially for early-stage biotechs. Here are strategies for avoiding some of the most common electronic publishing pitfalls on the path to submission.

  5. FDA Issues Guidance On Clinical Trials During COVID-19 3/25/2020

    In line with the challenges created by the COVID-19 pandemic, the FDA provided some recommendations with regard to the conduct, monitoring, and data aspects of ongoing and future clinical trials. Some of the key considerations for sponsors are below.

  6. Streamline Early Clinical Development With An INTERACT Meeting 3/9/2020

    Read how the INTERACT meeting can be an invaluable engagement with the agency to inform the successful planning and execution of a novel product development program.