Our Blog
Blog Post
Planning for a Successful Centralised Marketing Authorisation Application in the European Union
In the dynamic landscape of pharmaceuticals, obtaining a centralised marketing authorisation in the European Union (EU) is a crucial step for companies looking to bring their medicines to a broad market. The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications for centralised marketing authorizations in the EU, offering a streamlined process that enables companies to submit a single marketing authorisation application (MAA) and to market their products across the entire European Economic Area (EEA), which includes the EU countries, Iceland, Norway and Liechtenstein, based on a single authorisation.
Blog Post
How Many Strata can my Randomized Clinical Trial have?
When running a randomized clinical trial, if there are factors which are known during the study design phase to influence study results, it may be advantageous to utilize a stratified randomization which ensures each prognostic factor is balanced between treatment arms.
Blog Post
Handling Efficacy Data in Long-Term Ongoing Studies for a Submission
Regulatory reviewers will expect a Clinical Study Report (CSR) and supporting electronic data packages for these studies, but that doesn’t have to delay our filing date. We have outlined suggested techniques to provide the agency with everything they need to review the application, without compromising the integrity of the ongoing study.
Blog Post
Updated Guidance on Formal Meetings Between the FDA and Sponsors: What Has Changed?
In September 2023, the FDA announced a new draft guidance, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.” The new guidance provides recommendations for formal meetings conducted by industry sponsors or applicants with the FDA for the development of either drug or biological drug products and does not apply to abbreviated new drug applications, applications for biosimilar biological products, or medical devices.
Blog Post
Confirming Confirmatory Evidence
“Do the studies in our program meet the FDA standards for demonstrating effectiveness?” is a question that sponsors frequently ask here at Rho. Demonstrating the efficacy of your product is an integral component of an application, but the flexibility surrounding what qualifies as substantial evidence from the FDA’s perspective can often leave you scratching your head.
Blog Post
PRO Data in Cancer Clinical Trials
The US Food and Drug Administration (FDA) recently finalized a guidance document outlining the agency’s thinking on Submitting Patient-Reported Outcome Data Cancer clinical Trials. The guidance illustrates the importance of choosing a PRO vendor that is capable of capturing the recommended content and framework as source data if possible. This will reduce the need for time-consuming and potentially error prone data manipulation in SDTM and ADaM.
Blog Post
CDISC Standards for COAs using Item Response Theory (IRT)
The US Food and Drug Administration (FDA) recently finalized a guidance document outlining the agency’s thinking on Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory. The guidance lays out technical specifications to consider when submitting clinical outcome assessment (COA) information that uses Item Response Theory (IRT) in a marketing application.
Blog Post
Bringing a Medical Device or Drug to Market – Part 1: How to Tell if Your Product is a Medical Device or a Drug
Are you developing a new product and wondering whether it falls under the classification of a drug or a medical device? While some products clearly fit in one classification or the other, with advancements in science and technology, products can have features that blur the lines between drug and device. Navigating the regulatory landscape is often a complex but critical aspect of bringing your innovation to market. In this series, we will explore the regulatory mechanisms available to help you distinguish a medical device from a drug product and to utilize FDA’s regulatory pathways specific to each, particularly in early development.
Blog Post
FDA’s Benefit-Risk Framework for NDAs and BLAs: An Introduction
The Prescription Drug and User Fee Act (PDUFA), first enacted in 1992, was put in place to ensure timely FDA approval or licensure decisions of New Drug Applications (NDAs) and Biologics License Applications (BLAs). To streamline this decision-making process, the FDA developed a structured benefit-risk assessment framework designed to highlight uncertainties about a drug’s safety and efficacy in the indicated population and where new findings, as they become available in the post-market setting, can be incorporated into the framework.
Blog Post
‘Tis the Season: Shedding Light on Seasonal Affective Disorder
Seasonal affective disorder (SAD), also known as major depressive disorder with a seasonal pattern, is a condition of regularly recurring depressive episodes that most commonly occur in autumn and winter and remit during spring and summer. Despite the relatively high prevalence and morbidity of SAD, this disorder still often goes undiagnosed, in large part because health care professionals do not generally consider a potential seasonal pattern in a patient who presents with depression.