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Implementation of ICH M12 Guidance in 2024: What’s New for Drug Interactions?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) adopted a harmonized drug-drug interaction (DDI) guidance (ICH M12) in May 2024. The next step is for this guidance to be implemented by ICH members; the FDA and EMA have already implemented the guidance. Read our blog for key highlights of the 2024 ICH M12 Guidance.
Blog Post
FMQs vs SMQs
Sponsors often rely on Standardized MedDRA Queries (SMQs) to group adverse events for detection of safety signals across clinical trials. Additionally, the FDA has introduced their own version of adverse event groupings – FDA MedDRA Queries (FMQs). So, what’s the difference?
Blog Post
Successful Orphan Drug Designation Application in the European Union
Are you developing a new medicinal product for a rare disease and interested in applying for orphan drug designation (ODD) in the European Union (EU)? This blog lists the main areas that you will need to address in your ODD application.
Blog Post
Diversity Action Plans: A New Requirement for Phase 3 Clinical Trials. Are You Ready?
Diversity Action Plans will soon be required for phase 3 clinical trials and other pivotal studies of drugs and biological products conducted in the US. Are you ready for this requirement?
Blog Post
Statistical Challenges with Site Enrollment in Clinical Trials
Did you know that insufficient enrollment is the leading cause for clinical trials being halted? Study sponsors rightly embrace those sites which are high performing as they give a study the best opportunity to meet its enrollment targets. However, is it possible for there to be overreliance on these high enrolling sites? Unfortunately, the answer is yes.
Blog Post
Marketing Application Reviews: Best Practices for Responding to Information Requests
Responding to information requests (IRs) from FDA during review of a marketing application can be stressful. How do you survive the rollercoaster of requests? We have outlined useful tips and best practices for managing responses to IRs during FDA review of your marketing application.
Blog Post
Overcoming statistical challenges in rare disease drug development
Regulatory agencies like the FDA require substantial evidence of the drug’s effectiveness for its intended use and sufficient information to conclude that the drug is safe. However, flexibility is given in how the standard can be met given the challenges associated with the limited number of subjects available in rare disease.
Blog Post
Where did the odds ratios go?
Reviewing recent FDA approvals, you may be struck by the total absence of odds ratios. Browsing the labels from the 2023 novel approvals, you can find proportions, differences in proportions, Chi-Squared analyses, CMH and variants, but logistic regression and odds ratios have practically disappeared from labeling. What gives?
Blog Post
FDA’s Benefit-Risk Framework for NDAs and BLAs: The Presentation
FDA’s Benefit-Risk Framework is the presentation for communicating the assessment of the benefits and risks based on the therapeutic context, available evidence and uncertainties for the product in development.
Blog Post
Study-Size Adjusted Percentages in Integrated Adverse Event Displays
To those of us who regularly create or review adverse event (AE) incidence tables for randomized controlled trials, it may come as a surprise that your typical AE incidence table can be misleading if data was combined from more than one trial. This is due to “Simpson’s paradox,” which, simply put, is the phenomenon that the mere grouping of data can introduce confounding or bias otherwise not present.