On July 25, 2025, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) published a joint Request for Information (RFI) to solicit information and data to help the agencies develop a...more
7/31/2025
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As we reported in our recent client alert, the Trump administration has made clear that it is committed to using the False Claims Act (FCA) to prosecute healthcare fraud. Two recent Trump administration moves give important...more
7/21/2025
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Whistleblowers
On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a major initiative to voluntarily phase out “petroleum-based synthetic dyes” (i.e., synthetic...more
On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more
The U.S. Food & Drug Administration (FDA) issued two new versions of guidance documents for COVID-19 tests on January 12, 2023: Policy for Coronavirus Disease-2019 Tests (the “COVID-19 Test Guidance”) and Policy for...more
For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products....more