Regulatory Studies

Advancing LGBTQIA+ Representation: The FDA’s Role in Inclusive Diversity in Clinical Trials

Advancing LGBTQIA+ Representation: The FDA’s Role in Inclusive Diversity in Clinical Trials

by | Oct 14, 2024

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.

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Expanding Diversity: Beyond Clinical Trials to Human Factors and Label Comprehension

Expanding Diversity: Beyond Clinical Trials to Human Factors and Label Comprehension

by | Sep 9, 2024

At the end of April 2024, the FDA finalized its rule on Laboratory Developed Tests (LDTs), marking a significant regulatory shift. Labs now face a phased compliance process over four years, adapting to stringent requirements. SoundRocket specializes in human factors and user comprehension studies, essential for FDA submissions. We provide comprehensive support through user and label comprehension studies, simulated use studies, and regulatory guidance. With proven expertise in FDA submission support, SoundRocket ensures your LDTs meet regulatory standards efficiently. Embrace the new regulatory landscape with confidence by partnering with SoundRocket. Visit our services page to learn more.

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Insights on the FDA’s Virtual Public Meeting: Home as a Health Care Hub Initiative

Insights on the FDA’s Virtual Public Meeting: Home as a Health Care Hub Initiative

by | Aug 27, 2024

At the end of April 2024, the FDA finalized its rule on Laboratory Developed Tests (LDTs), marking a significant regulatory shift. Labs now face a phased compliance process over four years, adapting to stringent requirements. SoundRocket specializes in human factors and user comprehension studies, essential for FDA submissions. We provide comprehensive support through user and label comprehension studies, simulated use studies, and regulatory guidance. With proven expertise in FDA submission support, SoundRocket ensures your LDTs meet regulatory standards efficiently. Embrace the new regulatory landscape with confidence by partnering with SoundRocket. Visit our services page to learn more.

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Navigating the New FDA LDT FinalRule with SoundRocket’s Expertise

Navigating the New FDA LDT FinalRule with SoundRocket’s Expertise

by | May 17, 2024

At the end of April 2024, the FDA finalized its rule on Laboratory Developed Tests (LDTs), marking a significant regulatory shift. Labs now face a phased compliance process over four years, adapting to stringent requirements. SoundRocket specializes in human factors and user comprehension studies, essential for FDA submissions. We provide comprehensive support through user and label comprehension studies, simulated use studies, and regulatory guidance. With proven expertise in FDA submission support, SoundRocket ensures your LDTs meet regulatory standards efficiently. Embrace the new regulatory landscape with confidence by partnering with SoundRocket. Visit our services page to learn more.

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