Division of Clinical Research

Office of the Vice President and Innovation

Category results for: FDA

CDER Compliance Conference – January 14, 2021

CDER Compliance Conference January 14, 2021 | 9:00 a.m. – 3:30 p.m. Eastern This conference is FREE. Register here: https://www.fda.gov/drugs/news-events-human-drugs/cder-compliance-conference-01142021-01142021?utm_medium=email&utm_source=govdelivery TOPICS Compounding: Cleanrooms and cleanroom behaviors: why they matter Drug importation requirements Risk Evaluation and Mitigation Strategies (REMS) compliance program Drug Supply Chain Security Act implementation (DSCSA) implementation updates In SBIA’s first conference dedicated to compliance, participants […]

Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA

Join the CDER Small Business and Industry Assistance webinar Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA December 16, 2020 | 1:00 – 2:30 p.m. Eastern FREE Registration In this era of globalization, meeting various regulatory authorities’ expectations in recruitment of diverse trial population is challenging. The need for faster drug […]

CDER SBIA Regulatory Education for Industry (REdI) Annual Conference 2020 Recordings

Recordings and slides are available for the 2020 REdI Annual Conference. Day One  Real-world Evidence for Drugs, Biologics, and Devices So, Your NDA Was Approved – Now What?! Post-approval Responsibilities Obligations Restructure of the Office of New Drugs (OND) Overview of Postmarketing Drug Safety Reporting Requirements Enhanced Drug Distribution Security – DSCSA Implementation Updates Drug […]

FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

The final guidance issued on November 9th, “Enhancing the Diversity of Clinical Trial Populations–Eligibility Criteria, Enrollment Practices, and Trial Designs,” was first issued as a draft in 2019. It provides the FDA’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices, trial designs, and methodological approaches. The guidance aims […]

FDA OMHHE releases new video on medical device clinical trials

FDA’s Office of Minority Health and Health Equity released a new video about the importance of diverse participation in clinical research for medical devices. The FDA not only reviews new drugs, but the agency also reviews many medical devices before they are marketed to determine if they meet FDA’s safety and effectiveness standards. Diverse participation in clinical […]

FDA adds 25 regulatory science tools to help assess medical devices

The U.S. Food and Drug Administration (FDA) added 25 tools to the Catalog of Regulatory Science Tools to help assess medical devices. The tools include: Laboratory Accuracy Evaluation of Infrared Thermographs Benchmark Problems for Verifying Cardiac Electrophysiological Models Use of Newtonian Analog Fluids And 3D Printing to Evaluate Flow Rates of Diets In G-Tubes Confocal […]

Listening Session on the Digital Health Center of Excellence

The U.S. Food and Drug Administration (FDA) will host a virtual listening session for digital health device manufacturers, developers, health care providers, researchers, and other stakeholders to learn about the Digital Health Center of Excellence. During the session, the FDA will discuss the purpose and functions of the Center of Excellence and will focus on […]

Webinar Materials: Final Guidances on Safety and Performance Based Pathway Criteria for Certain Device Types

On September 24, 2020, the U.S. Food and Drug Administration (FDA) hosted a webinar for industry and other stakeholders interested in learning more about two final guidance documents that provide performance criteria for the following device types in support of the Safety and Performance Based Pathway:  Conventional Foley Catheters Cutaneous Electrodes for Recording Purposes  You […]

FDA virtual Town Hall for test developers on SARS-CoV-2

Oct. 7 from 12:15 – 1:15 p.m. On Wednesday, October 7, 2020, from 12:15 pm – 1:15 pm Eastern Time, the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for test developers for SARS-CoV-2. During this Town Hall, the FDA will answer technical questions about the development and validation of tests […]

FDA Launches the Digital Health Center of Excellence

The U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). This center will further the agency’s dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and […]

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