Biometrics teams can generate hundreds, if not thousands, of SAS programs throughout the drug development process. So how do you know which ones to submit to the FDA? And how do you go about submitting the programs?
Rho is thrilled to announce our unwavering support for Tonix Pharmaceuticals as they prepare to submit their New Drug Application (NDA). Serving as a dedicated partner to Tonix, we are committed to providing the necessary resources and expertise to support the next steps toward regulatory approval of Tonmya™ for the management of fibromyalgia. Our collaboration underscores our shared dedication to advancing healthcare solutions that improve patient outcomes and enhance the quality of life. We are grateful to be a part of such an exciting partnership as we continue to champion breakthrough advancements in drug development.
In September 2023, the FDA announced a new draft guidance, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.”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.
“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.
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.
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.
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.
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.
