Gottlieb, who led the agency during the first Trump presidency, supports a reversion to an earlier interpretation of the 21st Century Cures Act.

While a pause on federal health agencies is nothing new during presidential transitions, the Trump Administration’s ...

For more than a decade, the Food and Drug Administration (FDA) has made diversity in clinical trials a focus, including by issuing guidance, ...

The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...

Robert F. Kennedy Jr., President Donald Trump's pick to lead the top U.S. health agency, told U.S. senators during his ...

Robert F. Kennedy Jr. may soon be America's top pharmaceutical regulator. That is cause for concern in Seattle’s biotech ...

The website changes raise concerns about “the interference of politics with the study and the practice” of science and medicine, one physician said.

Key guidance to industry on enhancing diversity in clinical trials of cancer drugs disappeared from the Food and Drug Administration website. The page for Project Equity, a 2021 initiative ...

Last year, the company conducted 2 pre-submission meetings with the FDA review team for guidance on the initial stages of pre-clinical and clinical work supporting a Premarket Approval (PMA) ...

Project Equity wasn’t the first time the agency sought to address inclusivity problems in clinical trials, but it helped lead to the development of formal guidance around “diversity action plans.” ...

The Food and Drug Administration, a federal agency of the HHS ... Articles have been published virtually every Thursday for decades, detailing agency guidance, updates on disease outbreak ...

The Food and Drug Administration, a federal agency of the ... published virtually every Thursday for decades, detailing agency guidance, updates on disease outbreak investigations and studies ...