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.
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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.
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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use a randomized controlled trial (RCT) design rather than a single-arm trial in most cases, the FDA advises in new draft guidance issued last week.
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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.
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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.
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