What is ACNU? ACNU stands for "Additional Condition for Nonprescription Use," a regulatory framework introduced by the U.S. Food and Drug Administration (FDA) to make certain medications available over-the-counter (OTC) while ensuring they are safe and effective for...
Key Areas of Focus for Manufacturers Under the New Guidelines FDA self-selection studies are critical to the regulatory evaluation process, particularly for over-the-counter (OTC) drugs and direct-to-consumer (DTC) The FDA has recently finalized a rule about...
Laboratory Developed Tests (LDTs) have become an essential part of healthcare diagnostics. These specialized tests, developed and processed within CLIA-certified laboratories, offer customized solutions that help close diagnostic gaps left by commercial options. They are particularly important in areas where traditional diagnostics fall short, such as personalized healthcare.
Inclusive clinical trials are essential for ensuring that new treatments and medical interventions benefit all populations, particularly those historically underrepresented in research. By addressing barriers such as non-inclusive screening processes and lack of awareness in LGBTQIA+ communities, the FDA is making strides toward more diverse and representative clinical trial cohorts. This commitment to inclusivity will help create safer, more effective treatments that reflect the needs of all individuals, regardless of gender identity or sexual orientation.
This article will explain the difference between response rate and completion rate, why each matters, and how both can impact the overall data quality of your survey.
Learn about the FDA’s new regulatory changes for Laboratory Developed Tests (LDTs) and how they impact premarket review and authorization. Explore key takeaways and implications for healthcare providers and innovators
SoundRocket Founder and Chief Vision Officer Scott Crawford has been invited to speak on a virtual panel for the New York Chapter of American Association for Public Opinion Research (NYAAPOR) on Wednesday May 3rd from 6 - 7:30pm. Three other survey research...
When I first heard about the new artificial intelligence (AI) chat tool called ChatGPT (created and offered as a free research tool by OpenAI), I was excited to play with it. Social media was abuzz with others in professional fields who had identified ways that this...
This seminar is part of two seminar series: a seminar series hosted jointly by the Michigan Program in Survey and Data Science at the University of Michigan and the Joint Program in Survey Methodology at the University of Maryland the Inclusive Research...