Premier Consulting Blogs

  1. Fast Track Designations For Your 505(b)(2) Drug Development Program 6/6/2022

    One FDA tenet is to get safe, effective drugs to market as soon as possible. Understand the details of Fast Track designation (FTD) and how 505(b)(2) products can qualify for this program.

  2. Key Considerations For An Effective Commercial Strategy 5/11/2022

    Find out the questions sponsors can ask to ensure they have the best chance to develop an asset with commercial potential.

  3. Leverage FDA Feedback To Communicate Risk And Boost Confidence 5/11/2022

    In this blog, discover the tips and tricks to figuring out how to translate the FDA’s feedback into a compelling investor pitch.

  4. Single-Arm Trials Use Real-World Evidence For Rare Disease Drug Development 3/1/2022

    In rare disease product development, where a placebo control group may not be an option, a single-arm trial can be a successful approach. Gain insight into the regulatory considerations for single-arm trials.

  5. FDA INTERACT Meetings: Early Interactions For Cell And Gene Therapy Sponsors 3/1/2022

    Discover how the INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) meeting offers sponsors of biologics (industry and investigators) an avenue for engagement with CBER in early development discussions.

  6. Back To Basics: 505(b)(2) FAQs Part 3: Regulatory Strategies 2/24/2022

    As the 505(b)(2) expert, Premier Consulting is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Here is Part 3 in the series of frequently asked questions (FAQs).

  7. Considerations For Each Stage Of Drug Development 1/11/2022

    Get an overview of the critical planning activities and milestones in the drug development process, along with important regulatory considerations at each stage. 

  8. How Preclinical And Nonclinical Studies Differ, And Where They Belong 1/11/2022

    Learn when should each term be used, and the appropriate timelines for preclinical and nonclinical studies within a drug development program.

  9. Combination Device Regulatory Strategy: Success With The FDA 10/28/2021

    Breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Read how having an adaptive regulatory strategy is key.

  10. Advancing From Research To Development: What Can Go Wrong? 10/28/2021

    With many steps between drug discovery and regulatory approval, there are several factors to consider at the earliest stages. Find advice for avoiding major pitfalls during the drug development process.