Division of Clinical Research

Office of the Vice President and Innovation

Category results for: Policies & Guidance

FDA Posted Guidance Documents

New FDA Posted Guidance Documents 1/6/2021 – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff 1/6/2021 – Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff 1/5/2021 – Mouse Embryo Assay for Assisted Reproduction Technology Devices 1/5/2021 – Human Gene […]

FDA Final Guidance: Safer Technologies Program for Medical Devices

The U.S. Food and Drug Administration (FDA) issued final guidance outlining the Safer Technologies Program (STeP) for Medical Devices. This program will be a voluntary pathway for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics for diseases or conditions that are less serious […]

FDA DRAFT GUIDANCE “IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators”

This guidance is intended for sponsor-investigators developing individualized investigational antisense oligonucleotide (ASO) drug products for a severely debilitating or life-threatening genetic disease. Most often, individuals with such diseases will not have FDA-approved treatment options and their diseases will be rapidly progressing, resulting in early death and/or devastating irreversible morbidity within a short time frame. In […]

FDA Publishes Final Guidance for Controlled Correspondence Related to Generic Drug Development

On December 16, 2020, FDA announced the availability of the final guidance for industry entitled “Controlled Correspondence Related to Generic Drug Development.” This final guidance provides information on the following: Process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development Agency communications related […]

FDA Issues New Final Guidances on Safety and Performance Based Pathway Criteria for Certain Device Types

The U.S. Food and Drug Administration (FDA) issued three final guidance documents providing performance criteria for the following device types in support of the Safety and Performance Based Pathway: Spinal Plating Systems Orthopedic Non-Spinal Metallic Bone Screws and Washers Magnetic Resonance Receive-Only Coils Under the Safety and Performance Based Pathway, medical device manufacturers planning to submit […]

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 […]

New process for monitor access to EMR and patient records

COVID-19 has created many challenges and opportunities for clinical research over the last several months. One has been setting up the VCUHS site monitors with virtual access to our patient’s records.  There now is a solution in Cerner that is working for VCUHS monitors.  Now that it is known that the External Chart Auditor Cerner access […]

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 […]

FDA Issues Final Guidance on Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol

The FDA had issued this final guidance: Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol. Read the guidance The final guidance: Describes recommendations about what information industry should include in premarket submissions for medical devices containing nitinol. Outlines technical recommendations including mechanical, corrosion, and biocompatibility testing. Provides consensus standard references and terminology to aid […]

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