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Home » Newsletters » CenterWatch Weekly

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March 27, 2023

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  • CenterWatch Weekly, March 27, 2023
White House

Trial Stakeholders Advise White House on Emergency Research Infrastructure

Following a request for information by the White House’s Office of Science and Technology Policy (OSTP), a number of industry groups offered suggestions for priming the U.S. clinical research infrastructure to effectively respond to future public health emergencies. Read More
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Stress Levels Continue to Climb in Healthcare Workforce, Survey Finds

Healthcare workers’ levels of stress rose to a new high of more than 40 percent in 2022, putting them at greater risk of health and work performance issues, according to the latest in a series of annual surveys. Read More

Industry Briefs

FDA Guidance Advises RCTs for Oncology Drugs Seeking Accelerated Approval

Sponsors of new oncology drugs and biologics that aim to apply for Accelerated Approval (AA) should use a randomized controlled trial (RCT) design rather than a single-arm trial in most cases, the FDA advises in new draft guidance issued last week. Read More

FDA Framework Will Explore DHTs in Regulatory Decision-Making

The FDA is standing up a new program to provide a framework for regulators, researchers and the public to explore how digital health technologies (DHT) — such as mobile medical apps and wearable devices — can advance drug development. Read More

UK Proposes Sweeping Changes to Rules Governing Clinical Trials

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed major reforms to its clinical trial regulations, including a 30-day maximum for reviewing new trial applications and a 10-day maximum for granting a decision after receiving requested follow-up information. Read More

Drug & Device Pipeline News

Twenty-four drugs and devices were approved or entered a new trial phase last week. Read More

Research Center Profiles

Research Center Profiles are free to use and provide comprehensive listings of hundreds of institutional and independent sites. Read More

Upcoming Events

  • 12Apr

    The Patient Playbook Webinar Series, Part 3 — Rethinking the Development of Participant-Centric Clinical Trial Technology

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

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  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Five Ws

    Consider the Five ‘W’s to Understand Potential Participants

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    Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

  • White House

    Trial Stakeholders Advise White House on Emergency Research Infrastructure

  • SurveywBlueBackground-360x240.png

    Stress Levels Continue to Climb in Healthcare Workforce, Survey Finds

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