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The US Food and Drug Administration (FDA) released a draft guidance, “Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.” The purpose is to guide industry in accounting for patient and caregiver perspectives on living with a particular disease or condition and how medical devices impact their lives. The draft guidance is part of the FDA Patient Engagement Advisory Committee (PEAC) initiative to increase patient engagement in medical device clinical trials. The idea is that patients must be willing and able to use a medical device in order for it to have a practical benefit, so understanding any potential barriers prior to conducting a clinical trial would be beneficial.
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Topic: Contract Research Organization (CRO) Oversight after ICH E6(R2)
Date: October 22, 2019
Time: 1:00 p.m. – 2:00 p.m. EDT
Duration: 60 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session. Recording will be available for 30 days.
Sign up here.
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SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at the Association of Clinical Research Professionals (ACRP) New York Metropolitan Chapter’s symposium. Chapter members can receive 6.5 contact hours, and they are available for purchase for others.
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SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at the Association of Clinical Research Professionals (ACRP) Research Triangle Park (RTP) Chapter’s first regional conference. SAM will present on October 4th. Subject matter experts will cover key issues impacting clinical trials, and the conference provides networking opportunities and 12.0 ACRP continuing education credits are available.
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The U.S. Food and Drug Administration (FDA) released a final guidance, “Humanitarian Device Exemption (HDE) Program.” The guidance is in alignment with requirements from the 21st Century Cures Act and amendments to the Federal Food, Drug, and Cosmetic Act by the FDA Reauthorization Act of 2017 (FDARA).
The U.S. Food and Drug Administration (FDA) issued a Notice of Proposed Rulemaking (NPRM) in the Federal Register November 15, 2018 entitled, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” The NPRM seeks to amend regulations 21 CFR Parts 50, 312, and 812 in alignment with provisions in the 21st Century Cures Act (Cures Act). Our previous blog details the proposed rule.
The U.S. Food and Drug Administration (FDA) issued a Notice of Proposed Rulemaking (NPRM) in the Federal Register, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” The NPRM seeks to amend regulations 21 CFR Parts 50, 312, and 812 in alignment with provisions in the 21st Century Cures Act (Cures Act).