Introduction Questionnaire design is a cornerstone of survey research. It guides the development of questions, structures the survey, and ensures it achieves the intended research objectives. Strong design enhances the validity and reliability of the data collected in...
Navigating FDA regulatory compliance for medical devices is a multifaceted challenge that demands precision, expertise, and seamless collaboration. For medical device regulatory consultants and compliance-focused professionals, partnering with a specialized Contract...
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...
FDA self-selection studies are critical to the regulatory evaluation process, particularly for over-the-counter (OTC) drugs and direct-to-consumer (DTC) medical devices. These studies evaluate whether typical users can accurately choose if a health product is right...
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.
Explore how Patient Preference Information (PPI) impacts medical device development and regulatory submissions, with insights from the FDA’s draft guidance and key benefits for manufacturers.
Ensuring a positive campus experience for all students requires understanding each university’s campus climate – an essential part of guaranteeing a school’s sustainability for faculty and students alike. A campus climate survey is an excellent resource designed to...