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.
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?
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.
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.
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.
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?
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.
Cindy Visness, PhD, Rho’s Principal Research Scientist, worked with investigators on the NIAID-funded Urban Environment and Childhood Asthma (URECA) study to dissect the complex web of factors influencing respiratory health in city-living children in the article, “Relationships between lung function, allergy, and wheezing in urban children” available in The Journal of Allergy and Clinical Immunology April edition.
Sometimes relationships can continue even when things aren’t working out. However, when it comes to the partnership between a sponsor and its contract research organization (CRO), there isn’t any time to waste. Failing to address issues quickly during a clinical trial can cause issues.
