Blog — Clinical Pathways

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FDA Issues Revised Draft Guidance on Formal Meetings Between FDA and Applicants of PDUFA Products

10/24/2023

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On September 21, 2023, the Food and Drug Administration (FDA) released a revised draft guidance “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” to advise on formal meetings between the agency and sponsors or applicants involved in the development and review of investigational products. The new draft guidance replaces the previous version issued in December 2017.

EU Advice to Sponsors for Trials Impacted by Ukraine War

04/05/2022

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The European Commission (EC), the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) issued advice to sponsors on how to manage clinical trials that are impacted by the Russian invasion of Ukraine. Sponsors requested advice on how to manage protocol deviations, source documents, missing data, and other changes that are due to the ongoing Ukrainian war.

FDA Takes Action on Unreported Study Results; First Notice of Noncompliance

5/18/2021

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The US Food and Drug Administration (FDA) requires sponsors to register and report results to ClinicalTrials.gov (Clinical Trials Registration and Results Information Submission Final Rule). The purpose of listing and reporting in the public database is to increase transparency and increase scientific understanding, thus allowing others to build on knowledge already gained rather than duplicating work that may be unnecessary. If these requirements are not met, the FDA has authority to take enforcement action.

Sandra SAM Sather Speaking at ACRP RTP Regional Conference: October 3-4, 2019

9/27/2019

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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.

Live Webinar Identifying Workforce Gaps in RBM: August 13

7/30/2019

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Topic: Identifying Workforce Gaps Post Risk-Based Monitoring (RBM): It’s Time to “DIG” in!

Date: August 13, 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.