Halloran Insights

1. Success Planning For An Original NDA/BLA Submission 4/15/2024

   Experts in regulatory strategy, operations, and program leadership provide strategies for initiation triggers, team coordination, submission processes, and Electronic Submission Gateway (ESG).

2. Should You Bring Your Trial Master File In-House? 4/15/2024

   The decision to bring the TMF in-house or contract with a CRO depends on the specific needs and resources of the sponsor, and it is important to carefully consider the implications before making a decision.

3. Preparing Now For FDA’s START Program For Rare Disease Drug Developers 3/14/2024

   Delve into this overview of the START pilot program, expectations to consider if you are applying to the program, and early preparation considerations.

4. Bringing In Vitro Diagnostics To Market With Real-World Evidence 3/14/2024

   Explore the potential of real-world evidence in enhancing the regulatory decision-making process to facilitate the market entry of IVDs.

5. 5 Broad Implications For FDA’s Project Optimus 3/1/2024

   While formal guidance on the reform the dose optimization and dose selection is still pending, review five common themes that could help sponsors prepare for these changes.

6. The Value Of Artificial Intelligence To Support Inspection Readiness 3/1/2024

   Review three common inspection findings for overseeing all data and processes and ways that Artificial Intelligence can be integrated into an inspection readiness strategy.

7. Diversity In Clinical Trials: Shifting To Innovation Opportunities 3/1/2024

   Get an overview of the evolving landscape of clinical trials, where diversity and inclusivity are increasingly recognized as vital components of effective and comprehensive healthcare research.

8. Pulling The Thread On FDA’s Master Protocol Draft Guidance 3/1/2024

   Review this analysis of the draft guidance and its potential implications, as well as recommendations for companies planning to use master protocols in their clinical trials.

9. Reconsidering The 3+3 Dose Escalation In Oncology Studies 2/16/2024

   Learn why incorporating alternative study designs to efficiently determine a safe and optimal RP2D is paramount for clinical research in 2024 and beyond.

10. Implications Of FDA’s Final Guidance On Informed Consent 1/19/2024

    Watch this presentation for actionable insights to enhance the clarity, simplicity, and transparency of informed consent forms, ultimately improving participant experience and understanding.